Select Committee on European Communities Second Report - Written Evidence


Memorandum by Dr Chris Gliddon, School of Biological Sciences, University of Wales

1. PREAMBLE

  1.1 The following evidence relates to the problems associated with the lack of consistency of implementation and interpretation of Directive 90/220/EEC. Issues of harmonisation with the EU are addressed and suggestions for amendment of the Directive are addressed.

2. RISK

  2.1 A widely accepted definition of Risk is a measure of the effects (economic, injury, environment) of an occurrence in terms of both its probability and the magnitude of its consequences. This simple definition immediately requires that risk be decomposable into two main components: the hazard and its likelihood.

  2.2 Hazard can be defined as the property of a substance or a process that can cause harm. Hazard can never be zero; it can be direct or indirect, immediate or delayed, natural or technological, intentional or unintentional. Harm is the manifestation of that hazard. Given this, risk can be defined risk as the product of (1) the magnitude of the harm (generated by a hazard) and (2) the frequency with which the hazard occurs.

3. RISK ASSESSMENT AND RISK MANAGEMENT

  3.1 Risk assessment is the scientifically based process consisting of the identification and characterisation of hazards, the assessment of exposure and the characterisation of the resulting risk. Risk management is the process of weighing policy alternatives in the light of the results of the risk assessment and if required, selecting and implementing appropriate control options including regulatory measures. That is, risk assessment seeks to identify the hazards and determines the likelihood of their occurrence, i.e., the probability of something going wrong. Risk management then can, as a result of this process, allow necessary controls to be put into place to eliminate the hazard or, if this is not possible, to reduce the risk of the hazard causing harm.

  3.2 Environment risk assessment is the systematic evaluation of the risks associated with hazards to human health and safety and the environment, arising from human activities capable of impacting on the environment on a continuous or accidental basis.

4. The process of environmental risk assessment

  4.1 The following sequence of procedures for risk assessment has been proposed:

    (i)  identification of hazards;

    (ii)  estimation of their magnitude;

    (iii)  estimation of the frequency of their occurrence;

    (iv)  evaluation of risks.

  4.2 Risk assessment is feasible even in situations where current information is limited, providing its purposes and limitations are realised. Risk assessment should be an iterative process. The earliest analysis might determine where more information is needed to support credible risk assessments in future iterations and provide limited guidance in reducing risks to health and the environment through risk management and in the continuing decision-making process associated with remediation.

  4.3 The way to present the results of a risk assessment in which variability and uncertainty are acknowledged is controversial. This is often as a result of confusion regarding the difference between variability and uncertainty. Variability comprises a population's natural heterogeneity or diversity, which does not change through further measurement or study, although better sampling can improve an estimate of its magnitude. Uncertainty, in contrast, reflects gaps in information about scientifically observable phenomena. Uncertainty sometimes can be reduced through further measurement or study and several quantitative methods to describe risk-assessment uncertainties are currently being explored. Although there is general agreement as to the value of qualitative statements describing critical uncertainties in health risk assessment, formal quantitative approaches to uncertainty analysis are complex, difficult to perform, difficult to understand and often unnecessary. Variability, in contrast, can be described much more readily and can be based on actual measurements.

  4.4 Appropriate risk assessment consists of the application, in a systematic manner, of a wide range of scientific methods in order to master:

    (i)  how information is gathered systematically;

    (ii)  how its uncertainty is determined;

    (iii)  how potential future outcomes and their impacts are explored in an objective and reproducible manner;

    (iv)  how the likelihood of these outcomes is displayed clearly and comprehensively.

5. THE ACTUALITY OF ENVIRONMENTAL RISK ASSESSMENT

  5.1 A review of the current situation regarding applications for consent to market GMO's within the EU, with almost every application eventually being referred to the Article 21 Committee, shows clearly that environmental risk assessments are not performed and/or interpreted consistently among the various Member States.

  5.2 This lack of consistency seems to derive from (1) several weaknesses both in the present regulatory framework and the way it has been implemented nationally as well as from (2) significant gaps in the underlying science base.

6. THE REGULATORY FRAMEWORK

  6.1 Hazards cannot be zero and, as such, there is a risk associated with every release of a GMO. In this context, the use of the products of modern biotechnology is often perceived as a possible threat. It would be useful, therefore, if both regulators and consumers were able to balance potential risk against possible benefit. The scope of Directive 90/220 is to allow the release of a GMO based on an assessment of environmental safety and it would be in the interests of both consumers and regulators to broaden this scope to permit environmental risk to be balanced against environmental benefit.

  6.2 Environmental benefits can be direct or indirect and they should be assessed against direct as well as indirect environmental risks. As such, the scope of Directive 90/220 should be broadened in order to accommodate direct as well as indirect effects.

  6.3 When balancing risks against benefit we must also take into account that the "currencies" applied must be identical. Furthermore, a pragmatic approach is required when taking distant indirect effects into consideration. Their consequences become weak and therefore these should not get the same level of attention as close indirect effects or as direct effects.

  6.4 The regulatory framework should promote the exchange of views among experts on pertinent issues such as hazard definition in relation to crops with relevance for European biotechnology or for genes that are currently being released in experimental field trials.

  6.5 These experts could form a scientific committee that proposes to the European Commission projects that are worthy of being carried out. A demanding mandate could lead to a more efficient use of the committee that is composed of the representatives of the Member States and that has been set up under Article 21 of Directive 90/220/EEC to assist the Commission.

  6.6 The information requirement for Annexes II and III of Directive 90/220/EEC should be structured so that they can be directly related to the definition of the actual hazards related to the application.

  6.7 Directive 90/220/EEC should take account of the difference in data requirements between an application for a deliberate field trial and an application for a marketing dossier due to differences in both scale and location. A new annex III that is specific for multi-location, large scale marketing applications should be elaborated.

  6.8 Annex II and Annex III should distinguish between requirements for different groups of organisms.

  6.9 Administrative provisions should be made to allow for relevant data collection. An example is to allow for a single approval system for multi-state field trials that are considered as very important prerequisites for any commercialisation stage.

7. SCIENTIFIC LACUNAE

  7.1 While well over 8,000 releases of GMOs into the environment have been made world-wide, of which about 1,000 have taken place in Europe, many of these releases have been carried out with monitoring purely designed to ensure efficacy of any confinement requirements attached to the consent. As such, much scientific information of potential value for future risk assessment remains uncollected and there is a tendency to over-value the so-called familiarity with particular classes of GMOs.

  7.2 Hazard identification must depend largely on the availability of high quality data. Actions resulting in increasing the availability of data or improving their quality lead ultimately to an improvement of the processes of hazard identification and of risk assessment and should be encouraged.

  7.3 Expert advice should be organised at the Community level in relation to applications for consent to market.

  7.4 Apart from the need for the organisation of the expert advice, hazard identification becomes a more scientific process as more data becomes available. Therefore, both the continuing generation of high quality data and its exchange on an international basis will lead ultimately to a streamlining of the hazard identification process and should be encouraged.

  7.5 Data collection, data sharing and the compilation of databases that allow for the evaluation of the interaction of a GMO with a given ecosystem are generally recognised as an essential step forward. There is a need for a systematic collection and storage of a thoroughly investigated set of information so that hazard and the concomitant risk analysis can be performed on an internationally accepted basis.

  7.6 Data should be obtained from the field testing of genetically modified organisms in which some of the environmental and safety concerns match those of the marketing stage. Broad geographical field testing therefore enhances European wide experience with a specific GMO. This in turn should have a positive effect on the consideration of possible hazards involved at the marketing stage and at the approval process in all Member States.

  7.7 It is not possible to compile a positive list of all hazards that need to be taken into consideration in any risk assessment dossier. Some types of hazards, such as persistence of the GMO in nature might always appear in a risk assessment dossier whereas other hazards, such as the creation of new plant pests, are dossier-specific.

  7.8 Hazards might be specific for a geographical location or for a given ecosystem. A product dossier, although originating from one Member State, should ideally take into consideration all possible hazards for all possible European environments.

  7.9 Hazards differ when formulated by different individuals. It is extremely important to assemble a list of perceived hazards that is complete on the one hand but sufficiently restricted on the other hand.

  7.10 Directive 90/220/EEC should be modified with respect to hazard definition for the commercialisation of transgenic crops. At present, only those hazards that are directly related to the protection of human health and the environment are taken into consideration. All hazards and hazard categories pertinent to commercialisation should fall within the scope of any future modifications to the Directive.

  7.11 Definition and identification of hazards are based on knowledge. An appropriate framework should be constructed to permit the definition of hazards with an intellectual input that is as high as possible.

8. LIMITATIONS OF QUANTITATIVE RISK ASSESSMENT AS APPLIED TO GMOS

  8.1 The traditional framework for risk assessment and management, drawn from expertise with chemical products, involves a methodological progression through a rigorous sequence of analytical steps, including hazard identification, exposure assessment and, ultimately, risk-cost benefit assessment. The bio-ecological phenomena related to environmental releases of GMOs, however, do not submit neatly to this quantitative approach, due to the complexity of the phenomena and the scarcity of relevant data.

  8.2 When organisms are released into an ecosystem, it must be realised that the various pathways of outcomes and consequences are far too numerous for detailed empirical investigations. Scientists must rely on a judgmental analysis and on reasoning by analogy.

  8.3 Environmental risk assessment is still far from providing a standardised methodology that is based on data on occurrence probabilities and data from tests on effects of this release.

  8.4 High quality review and test data provide the basis for decision making. Data should be collected/generated such that they can be interpreted and in a hazard-oriented model.

  8.5 Experience should be fully appreciated in the risk assessment process and, for those areas where experience is lacking, experts should clearly define the need for generating research data.

  8.6 The responsibility for evaluating an environmental release must thus invoke a considerable degree of scientific knowledge and qualitative judgment in order to anticipate potential harmful consequences and to balance it against the available alternatives.



 
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