89.  The risks involved in genetic modification can, we believe, be controlled, if a strict risk management process is in place. Such a process includes hazard identification, risk assessment, procedures to minimise risk and systems for disaster management. In examining these issues, we first questioned whether the current regulatory approach was appropriate.

THE RISKS ARE NOT UNIQUE TO GENETIC MODIFICATION

90.  In much of the evidence we received, witnesses did not distinguish between risks inherent in or particular to the new technology and risks present in standard agricultural practice, when most of the processes used in agriculture may face the same criticisms as those levelled against the agricultural systems produced by the new technology. Genetically modified organisms therefore need to be placed in the context of their agricultural use. Risk assessment is inadequate if it considers a crop in isolation. In assessing risk, we recommend that modified plants and their management schedules[131] should be compared to the use of a similar non-modified crop and best agricultural practice. The comparison should take account of the chemical usage and agricultural practice involved in growing both crops. For example, any negative effects of a pest resistant crop must be weighed against the use of the conventional pesticides on a conventional crop. It is encouraging to see that this is to be the approach taken by the Pesticides Safety Directorate (Q 603).

91.  Some countries have adopted systems which consider the risks associated with the introduction of new varieties of crop plants into the environment. The Canadian regulations are not specific to GMOs and evaluations "are conducted on the basis of the unique characteristics of each product rather than the method of production. All plants with novel traits are assessed for possible impacts on the environment based on the specific modification and the biology of the plant" (p 300). While favouring the Canadian approach, we recognise that it is unlikely to secure acceptance in Europe. We recommend however that there should be triggers other than genetic modification which bring the assessment and management system into action, as is the case for novel foods. We recommend that, from now on, any crop with novel traits (or novel to a particular environment) which may have the potential to impact significantly on the environment should be subject to an oversight system. For example, conventionally bred herbicide tolerant crops are currently not subject to a monitoring programme. We consider that they should be subject to the same monitoring under the same systems as a GM herbicide tolerant crop.

RISK ASSESSMENT

92.  The risk posed to the environment by every genetically modified plant is assessed before it is released. Normally, the assessment attempts to quantify risk and therefore, if necessary, enables risk management to minimise the impact on the environment. There are however differences in understanding of what constitutes risk amongst the Member States of the Community and as to what is and is not a valid risk assessment consideration (Green Alliance, pp 72-3; Dr Gliddon, p 340). Professor James called for an agreement (at EC level) on acceptable risk relating to GMOs (Q 672). Until this was resolved, there could be little progress with consensus. We agree. In this respect, the Commission's attempt to define risk assessment principles is a much-needed part of the revised Directive. If approvals are to remain Community-wide, there must be a recognised standard as to what constitutes an unacceptable effect of a release.

93.  The principles of risk assessment identified in the draft Directive were however seen to be unacceptable by some witnesses. While agreeing that the principles and their application need to be standardised, the proposals were not seen as meeting the requirements for scientific evaluation, the needs of industry or the concerns of the public. Professor Williamson believed that the annexes which attempt to define the principles and information requirements "are so hopeless that they should start again from scratch" (Q 531). Dr Gliddon suggested that annexes II and III of the draft Directive "should be structured so that they can be directly related to the definition of the actual hazards related to the application". In addition he recommended that "a new annex III that is specific for multi-location, large scale marketing applications should be elaborated" (p 341). He also criticised the annexes for not providing a clear link between the information required and the risk analysis that follows. A clear, coherent set of principles for environmental impact analysis is needed which allows for consistent interpretation by Member States. The annexes must be redrafted in order to ensure that the principles underlying the impact analysis have the widest possible acceptance.

—INDIRECT AND CUMULATIVE EFFECTS

94.  The greatest present gap in the risk assessment as practised by the EC and United Kingdom today is that there is inadequate consideration of indirect and cumulative effects (Green Alliance, p 72; CWS, p 310). This is more important when considering licensing for commercial use than for trial releases, as the latter involves a particular experiment in a particular location (DETR, p 187). We recommend that risk assessment procedures should consider the ecological effects which arise from the inclusion of herbicide tolerance and pest resistance into crops (SNCAs, p 318), as well as the changes that are likely to arise as further variants of major crops become available. Major changes to crop management, which might include alterations to normal rotation schedules, may have an impact on the environment which need consideration when assessing risk. The issues of the super weed, multiple tolerances, pest resistance and indirect agricultural and ecological effects could conceivably become problems if indirect and cumulative effects remain outside the scope of risk assessments. We recommend that, as proposed, the risk assessment should include direct, indirect, immediate and delayed effects, but the manner in which risk assessment is related to impacts on biodiversity, sustainable development, agronomic and conventional agricultural practice must be clarified (Dr von Schomberg, p 404).

95.  Once a crop has been approved for commercial release it forms part of the environment and risk assessments for the introduction of subsequent crops have to take its presence into account. Thus, in considering the potential environmental impact of a crop modified to tolerate a herbicide, the risk assessment must take into account the environment, including other sexually compatible herbicide resistant plants. We recommend that a regulatory system which attempted to predict interactions of this sort and attempted to identify an integrated approach would be preferable to what amounts to a first come, first served approach. At the simplest level, guidelines could be set as to which herbicide tolerances might be incorporated into which crops, for example herbicide x into wheats and herbicide y into oilseed rapes. This would enable effects on, for example, rotation sequences to be anticipated and planned.

UNCERTAINTIES AND THE PRECAUTIONARY PRINCIPLE

96.  Thorough though it may be, risk assessment is but the first part of the process. Although it is possible to identify in a qualitative manner many of the hazards which might result from the use of GMOs, Dr Gliddon noted that it was difficult to quantify their impact (p 342) and there were strong calls for risk management procedures to acknowledge the inherent uncertainties (CA, p 52; Green Alliance, p 74). The Consumers' Association was critical when commenting on the methods used for managing risks, arguing that there are limitations to our scientific knowledge which mean "we do not always know what we do not know". While scientific advice is an essential part of the decision making process, it has limitations which mean that "it is not always sufficiently developed to be the sole basis for decisions" (p 52). The impact of new organisms released into an ecosystem can follow so many paths that scientists can only rely on judgmental analysis and on reasoning by analogy (Greenpeace, p 33). Professor Williamson provided us with a number of examples of introductions into similar environments that had substantially different impacts (p 213; Q 533).

97.  The Directive has been seen as the first attempt to implement the precautionary principle[132] in regulation (Dr von Schomberg, pp 401-2). The United Kingdom has interpreted the principle to mean that a "step-by-step" and "case-by-case" approach should be taken when releasing genetically modified organisms into the environment. The Minister for the Environment (Mr Meacher) illustrated this by saying that "practical evidence on safety" was required before deciding whether to allow a commercial release (Q 603). Professor James and Dr Chesson were however concerned that the principle might be taken to an extreme and become an excuse for inaction (Q 669). It is recognised that the data on which to base a risk assessment is not available purely from laboratory experiments and thus in many cases a limited environmental release is needed in order to gather information so as to decide on the safety of subsequent, larger-scale releases. The precautionary principle is meant to be implemented in the United Kingdom (DETR, Q448; CA p 50), but its step-by-step approach can only work if the results of each trial release are used to identify safety procedures for (or the inherent safety of) subsequent experiments and if uncertainties are acknowledged (Green Alliance p 73). In the same way as common principles are being agreed for risk assessment, the Community should try to agree an understanding of the precautionary principle, lest it become an excuse for inaction and nothing be allowed to proceed. The result should be a clear understanding of a step-by-step, case-by-case approach.

IS A MORATORIUM NEEDED?

98.  The initial focus on herbicide tolerance and pest resistance, both of which have potential environmental impacts, has been seen by many as sufficient to justify a moratorium on commercial releases into the environment until the issues have been researched and clarified (SNCAs, p 319). Trial releases are designed to minimise risk and therefore do not generally provide enough information on ecological or agricultural disruption to be useful for identifying risks to the environment of larger scale, uncontrolled releases (as with commercial exploitation) even if monitoring was required. Professor Beringer considered that trial releases tell us that the plant is growing properly, but provide little evidence as to ecological behaviour (Q 9; also Professor Williamson, Q 505). Plant variety registration trials ensure that the plant is uniform and stable, but remain too small to provide data on the environmental impact of the introduction. Professor Williamson suggested that the data could only be obtained through the monitoring of large scale releases conducted on a commercial scale (QQ 507-9) (see also paragraph 98). Professor Bainbridge was opposed to a moratorium on the grounds that what was needed was more research, not a halt to it; that it was possible that the end of a moratorium would never be triggered; that we had to be mindful of competitiveness; and that a moratorium could not be enforced globally (Q 716). We agree with those witnesses who said that large-scale trials were necessary[133]. The knowledge of how a crop grown on farm and commercial scales will interact with the environment can only be acquired by growing it on such scales. We consider that an outright moratorium would be inappropriate.

99.  The Government now appear to have reached agreement with the industry on a way forward. Herbicide tolerant crops are to be put on trial on a "farm-scale" basis prior to making them available for widespread use and research is to be conducted into the agricultural system which results from their use (Mr Meacher and Mr Rooker, Q 603). The time-scale for the farm-scale trials is unlikely to cause much additional delay to the commercial exploitation of GM crops as EC marketing approvals and commercial availability of suitable varieties and seed would, in the normal course of events, be unlikely to enable them to be used sooner. If all proceeds according to plan, this is a satisfactory solution, even in relation to pest-resistant plants which are to be subject to a three year restraint. We must however be sure to avoid any unnecessary delay which might jeopardise the position of our farming industry. Additionally, detailed targets must be set for what is to be achieved during this period and the appropriate research must thus be commissioned at the earliest opportunity. Such a period loses its utility if such objectives are not set.

COMMERCIAL RELEASES

100.  The draft Directive provides the means to approve commercial releases subject to conditions; in particular, modified crops would have to be monitored for direct and indirect effects on the environment. We welcome the ability to set specific conditions for each release. The Community should set any compulsory conditions and these should then be able to be strengthened by Member States if desired[134]. This facility can also be envisaged as a way to gather the fullest environmental data while allowing commercial releases to proceed faster than has occurred to date.

101.  We are however concerned that the draft Directive does not envisage an end-point at which the GM crop is considered safe enough to be released into the environment without such constraints (though perhaps with certain management conditions[135]) (see also Seven year consents, paragraph 170). After an initial, monitored commercial release, the product (if judged to be safe) should be granted an open-ended commercial licence, subject only to any necessary management conditions and the requirement to inform the competent authority of any data which requires a change to the environmental assessment. Additionally, many future modifications (such as soya with altered oil properties) may not have the environmental implications of herbicide tolerant and pest resistant crops and, subject to satisfactory trials, should be able to bypass the initial form of commercial release and be placed on the market without restriction. This is especially important as, if it is felt necessary to set conditions for every release, it is possible that cases of genuine concern will not be discerned from others.

MONITORING

102.  The statutory nature conservation agencies recommended statutory monitoring until there was clear evidence that GMO systems were viable, safe and sustainable (p 318). Novartis commented that the absence of rules for monitoring after commercialisation is a major current flaw. "There is a broad consensus in the field that good monitoring makes good business sense as well as being environmentally sound" (pp 372-3). The draft Directive requires applicants to provide a detailed plan for monitoring to include "direct, indirect, immediate or delayed effects on human health and/or the environment"[136]. Monitoring is not a substitute for risk assessment but can complement it. We consider that those involved should report on any predicted effects which do not occur and any unexpected events which do occur. For trial releases, nil returns should also be required, so that those monitoring have the fullest information possible. The permit-holder must be reminded that any information which might modify a risk assessment and risk management requires a modification of the consent and that they must inform the regulatory authorities. We are concerned that the Directive's recommendation is for the applicant (the seed company) to perform the monitoring, without the intervention of any outside body, whether as monitor or auditor[137]. We recommend that monitoring (to Community-wide standards) should be performed by an independent organisation, funded through levies on applicants. If a dedicated monitoring organisation is not to be established, the tender might be given by Member State governments to universities. There must also be a Community-wide audit of enforcement as monitoring standards (in many fields) have in the past been subject to too great a variation.

103.  While detailed monitoring as proposed is appropriate and feasible for trial releases and probably for the initial phase of commercial releases (along the lines indicated by Mr Meacher (QQ 611-12)), where full commercialisation is concerned the product is presumably already judged to be stable and safe and large geographic areas are likely to be involved. At this point, farmers are in a good position to notice the unusual and problematic, but they would need much agronomic and ecological assistance, particularly on what to look for, how to report and to whom, especially where they are asked to note the impact of their crops on the non-agricultural environment. Those involved in setting up these structures could learn from the approach adopted throughout the world to monitoring pharmaceuticals, the adverse reaction reporting system[138], whereby doctors[139] report perceived adverse reactions in patients. In the United Kingdom, these reports are then investigated and corroboration is sought from the General Practice Research Database. Supervision, for GMOs at present conducted by the HSE, would also be necessary as the system should not be solely dependent on spontaneous response. In any event, it would be irresponsible to require monitoring without first considering the consequences and structures which need to be in place, or without setting specific, measurable objectives. An absence of adverse results, through the use of very few (or inappropriate) indicators, is likely to breed false confidence that nothing is wrong.

104.  Everyone acknowledges the importance of monitoring, but it is a costly exercise. If the cost of monitoring is to be borne by the agro-chemical/seed companies, (who are but one part of the chain which benefits from genetic modification) it must be done responsibly and even-handedly. Professor Bainbridge considered that, while erring on the side of caution, we had to be mindful of issues such as industrial competitiveness (QQ 673, 716) (see also paragraph 171).

CONDITIONS ATTACHED TO RELEASES

105.  Conditions and regulations should only be imposed where necessary, that is, consistent with the precautionary approach, but must be adhered to when imposed[140]. We should remember that, as well as dealing with the regulation of a new technology, we are dealing with products dependent on commercial success. It is likely however that each type of modification (for example herbicide tolerance) will need to be subject to general conditions as to its handling and that each particular crop may require some specific conditions dependent on its characteristics.

106.  The general conditions may best be established through a (preferably pan-European[141]) government-sponsored code of practice. Farmers and industry are in need of comprehensive, standardised guidance as to how to handle GM from seed sack to shop shelf. Such a code needs to embrace, amongst other things, buffer zones[142] between crops, the use of non-selective herbicides (perhaps once in a given crop rotation), rotation sequences[143], refuges[144] of non-GM or untreated crops, geographic zoning[145], farm saved seed and (if required) traceability[146]. Finally, the code should include a plan for recovery in relevant situations.

107.  The Government's approach has been to urge biotechnology's proponents (in the form of SCIMAC[147]) to prepare a code and then the Government will assess the finished product to see whether it meets their approval (QQ 603-4). Professor James argued that all sides of the debate needed to be involved (Q 669). We welcome the work being undertaken by SCIMAC to deliver a code with the support of Government. The statutory nature conservation agencies and other groups should certainly be involved as the code is unlikely to command authority unless it is agreed by all sides in the debate. It may be the case in this instance that a voluntary code of practice will not be sufficient; if so, current practice in relation to pesticides (a code of practice backed-up by regulation) should be adopted.

PRODUCT LEGISLATION

108.  The DETR was concerned at the Commission's intention to remove from the scope of the Directive trial releases where the product is covered by product-specific legislation (Dr Smith, Q 435). Professor James was also concerned that the move to product legislation could result, at Community level, in issues falling between the gaps of committees' remits (Q 663). Dr Chesson recommended a one stop process whereby a composite committee responded to all the different pieces of vertical legislation (Q 663). We share these concerns. Trial food crops are not food, and it is their impact on the environment that is important rather than their qualities as a food. Each product must be considered within the terms of the most appropriate legislation, and for products under development released into the environment this is the appropriate legislation. For commercial releases, however, product legislation is indeed more appropriate, provided that there is a comparable risk assessment and management process.