Royal Commission on Environmental Pollution

The Royal Commission on Environmental Pollution, whose 1989 report shaped the legislation which controls GMOs in the environment, says the issues now have to be looked at in a broader and more fundamental way.

Responding to the government consultation paper on future oversight of developments in biotechnology, the Chairman, Professor Sir Tom Blundell FRS, says the Royal Commission has sought to apply to GMOs the general conclusions about environmental policies reached in its report last year on Setting Environmental Standards.

The Royal Commission highlights as crucial factors the decline in public confidence in expert judgements, better understanding of the uncertainties inherent in scientific assessments, and the importance of bringing people's values to bear on environmental issues.

The Royal Commission calls for the present committees giving scientific advice about GMOs to be parallelled by machinery that will enable people's values to be taken into account in the way policy questions are framed, as well as in the eventual regulatory decisions about GMOs. The new machinery should be wider in scope than the 'environmental stakeholder forum' which has been suggested. The emphasis should be on the values and evolving views of ordinary citizens, not on brokering compromises between the settled positions of existing interest groups. Transparency is vital, and the Royal Commission says every official decision about GMOs must be accompanied by an explanation of the reasons for it.

A copy of the response submitted by the Royal Commission to the government's Office of Science and Technology is below.

Additional Information:

The Royal Commission's Thirteenth Report, The Release of Genetically Engineered Organisms to the Environment was published in July 1989 (Cm 720). It contained detailed recommendations for a statutory framework for control which were largely accepted by the government. The Commission's Fourteenth Report, GENHAZ, a system for the critical appraisal of proposals to release genetically modified organisms into the environment, was published in June 1991 (Cm 1557). It described a methodology developed from one used in the design of safe manufacturing plant (Hazop) for identifying potential hazards associated with GMOs. The government considered it too detailed to be generally applied.

Both reports are available from The Stationery Office. The government's consultation paper, Review of the Framework for Overseeing Developments in Biotechnology, was issued by the Office of Science and Technology on 21 December 1998.

The Royal Commission on Environmental Pollution is an independent standing body. Its terms of reference are to advise on matters, both national and international, concerning the pollution of the environment; the adequacy of research in this field; and the future possibilities of danger to the environment. Members of the Commission are appointed by Her Majesty The Queen on the advice of the Prime Minister and serve part time.

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REVIEW OF THE FRAMEWORK FOR OVERSEEING DEVELOPMENTS IN BIOTECHNOLOGY

RESPONSE BY THE ROYAL COMMISSION ON ENVIRONMENTAL POLLUTION

1. The Commission studied the release of GMOs in its Thirteenth Report, published in 1989. In order to provide safeguards in the face of the uncertainties attaching to the release of GMOs it recommended that a detailed scheme of statutory regulation should be established. The government accepted almost all of these recommendations and they form the basis of the legal provisions which now regulate GMO releases. In 1993, the Commission reaffirmed its confidence in the arrangements for regulating the deliberate release of GMOs to the environment.
2. The Commission's Fourteenth Report, GENHAZ, published in 1991, described a methodology for identifying the hazards associated with GMOs. This methodology was designed to make those responsible for appraising proposed releases approach them in an interdisciplinary way and employ lateral thinking to identify unfamiliar interactions. The government commissioned two trials of the procedure but considered it too detailed for general application. It also considered it likely to restrict flexibility in dealing with applications presenting different degrees of risk.
3. Since then, the decline in public confidence in expert judgement and changes in the understanding of environmental problems have led the Commission to look at the issues involved in a broader and more fundamental way. The climate of public opinion in which releases of GMOs are regulated is now even more mistrustful and critical than was previously assumed (question 8 of OST's consultation paper). The view that better explanation of the science is enough to secure public acceptance of experts' judgements is largely discredited. The Commission's Twenty-first Report pointed to signs of an erosion of trust in regulation, reinforced by a lack of confidence in government scientists, by pressures for deregulation, by a belief that uncertainties are played down in official statements, by criticisms of a perceived lack of openness, by an alleged lack of independence among some regulators, and by a failure to take sufficient account of people's values. The BSE crisis has led people to be wary of the claimed advantages of more efficient production and of official reassurances which equate 'no evidence' with 'no risk'. Many now question the validity of the traditional paradigm of government regulation informed by small groups of experts as an appropriate way of making policy in conditions of uncertainty.
4. Alongside these changes in the climate of environmental protection, some specific weaknesses have been identified in the system for regulating releases of GMOs. Biological systems are unpredictable in their response to stresses, especially in the ecological context. The type of risk assessment required under the current system attempts to cope with this by identifying hazards associated with particular GMOs, considering how each hazard could be realised, and then estimating the magnitude and likelihood of harm's being realised. The next stage is to estimate the risk of harm in respect of each hazard, modify the proposal until the lowest level of risk is obtained and then estimate the overall risk of harm to the environment. The assessment is carried out by the applicant who seeks the consent to release.
5. There is an attraction in reducing complex issues into a series of steps of this kind but in doing so certain issues become obscured and others can be overlooked.
6. First, the assumptions built into the estimates of hazard and risk are necessarily those of the experts employed by the applicant. They may well not be shared by others in society but the regulator, working in a regime tightly controlled by legislation, is not necessarily in a position to query them or to substitute other assumptions. There is also concern that the advisory committees are dominated by people whose views of the uncertainties surrounding the release of GMOs may not be shared by people from different backgrounds and with different values.
7. Second, for the public to find the decisions of the regulators acceptable requires a degree of trust in those regulators. As indicated above and as subsequent studies (such as the recent MAFF R & D Surveillance Report 361) have amply shown, it is precisely this trust which is now being eroded.
8. Third, the case by case approach to authorising releases does not consider the possible cumulative effects of several releases in the same area or of the indirect effects of releases, for example as products pass through the food web. The lessons to be drawn from pesticide use seem not to have been fully learned and there have been calls for changes to the regulatory structure to take account of such broader concerns.
9. Finally, there is an implicit assumption that the advantage to the applicant of the release can be weighed against the possible disadvantages to mankind and the environment, now and in the future. Making trade-offs of this kind is far from straightforward. It is difficult if not impossible for a reductionist risk assessment procedure to weigh, for example, moral objections to the use of certain GMOs against the prospect of financial reward to the user, or to judge the benefits to be gained from GMOs against the possibly small risk of a catastrophic but unspecific outcome.
10. There is, then, a considerable gap in the existing regulatory structure in relation to ethical and other wider issues (question 5 in the consultation paper). It is symptomatic of a deeper failure, the lack of a satisfactory and systematic means of taking public values into account.
11. The Royal Commission's Twenty-first Report characterised values in the following way.

    "We understand values to be beliefs, either individual or social, about what is important in life, and thus about the ends or objectives which should govern and shape public policies. Once formed, such beliefs may be durable. It is also characteristic that they may be both formed and modified as a result of information and reflection. Environmental and social values, in particular, are not necessarily preformed or fixed but, for many people, emerge out of debate, discussion and challenge, as they encounter new facts, insights and judgements contributed by others."(Paragraph 7.3)

12. Individuals are likely to have other values alongside values about the environment, and these will have implications for the way environmental values are pursued, and vice versa. There are many situations in which different values are competing with each other and there may therefore be difficulty in choosing the right course of action. This is bound to be the case in societies made up of individuals with contrasting backgrounds and sets of commitments. In such circumstances, finding the best way forward involves considering a range of policy options and identifying the one which comes closest to satisfying the values relevant to a particular decision. As well as facilitating the emergence of values, processes of debate and discussion may also help to resolve situations of competing values and thereby help to create or identify policy choices which will command wide support.
13. Parliamentary committees can perform an important function in weighing up opposing opinions but, whilst they can express public attitudes and values to some extent, there is a need for more direct methods of ensuring that people's values are articulated and taken into account alongside technical and scientific considerations when questions are framed and policies developed. None of the bodies in the existing regulatory system appears to have either the right kind of membership or a sufficiently wide remit (covering all aspects of genetic modification and all relevant government departments) to carry out this function. Fresh machinery will be needed.
14. An environmental stakeholder forum has been proposed as an addition to the current framework (question 6 of the consultation paper). As described last October in government evidence to the House of Lords Select Committee on the European Communities, this would include everyone with an interest, such as farmers, plant breeders, conservation bodies and public interest groups. It would act in parallel with the Advisory Committee on Releases to the Environment which would remain a scientifically based committee, considering applications on a case by case basis. Whilst stakeholders certainly should be consulted when decisions on GMOs are taken, the interests of stakeholders do not cover the whole spectrum of moral and social concern. Stakeholders have a clear, settled interest in an issue. The model of a stakeholder forum places the emphasis on negotiation and compromise instead of teasing out the implications of issues and thereby enabling mutual learning to take place, views to evolve, and a more robust conclusion to be reached. It is the values of people in their capacity as citizens which need to be included in the debate.
15. To enable people's values to be articulated, the Twenty-first Report envisaged machinery operating in parallel with existing technical and scientific sources of advice and feeding into key stages of the regulatory procedure. In the case of GMOs, this might consist of a body sufficiently well-resourced to commission work to elicit people's values using innovative approaches, including consensus conferences (regional and local as well as national), citizens' panels, focus groups and other kinds of workshop. It might also explore interactive use of the Internet. Public opinion surveys alone will not be adequate. The Office of Science and Technology has already initiated some activities of this kind, linked to use of the People's Panel. To reduce the dominance of centralised, metropolitan views, it would be desirable to use a range of organisations such as libraries, local authorities, universities and cultural organisations across the country as agents of the commissioning body. It would be important for this body to be independent of existing regulators and the biotechnology industry. But there should be contact and co-ordination between the component bodies in the regulatory system because they rely on each other for data and assumptions.
16. The output from the debate must be used effectively in the decision-making process. Talking shops with no real influence would have neither credibility nor value. In particular the output needs to inform the framing of questions about the way proposals for releases should be handled and the way policy aims are formulated.
17. In terms of the regulation of GMOs, the implication is for a formal reporting line from the body responsible for eliciting public values to the bodies which set the regulatory framework (civil servants and Ministers) and decide on specific applications. The Twenty-first Report did not envisage a hierarchical structure: each advisory body (scientific, ethical etc) has its own function but the bodies need to be able to interact, so that issues considered by, for example, a scientific advisory body are informed by people's values, just as those values can be adequately developed only with the help of reliable information from scientists. In order to achieve transparency, each body's output (which should be in the public domain) should be considered together with the outputs from the other bodies involved.
18. The attempt to map the contours of people's values is a necessary preliminary to informed and robust debate, but is not a panacea. The debate may be imperfect, information may be inadequate, and presentation selective. Some of the most difficult issues which are raised by the release of GMOs relate to the ways in which development can be made sustainable and here assumptions must be made about the values of future generations. In any case, there is a wide range of diverse values to be found between societies across the world as well as within them. It seems, for example, that the release of GMOs may cause less concern in the USA than in Europe. These differences can come into sharp conflict when they are between different communities linked by trade. Global dialogue in the WTO and in other international fora will be needed as well as what is done domestically and in the European Union. Moreover, whilst policies must reflect people's values, so too must they be informed by the best scientific, technological, economic and other analysis. The information available to experts and non-experts alike should be continually improved to raise the standard of the debate. The debate itself should be structured so that the underlying assumptions and values are made explicit.
19. Concern for transparency (question 4 of the consultation paper) goes deeper than this. People need to be able to satisfy themselves that all the factors have been given due weight when decisions are taken. At present there seems to be no means of achieving that. One solution would be to place an obligation on decision-makers to issue reasoned decisions, as there is, for example, when Town and Country Planning appeals are decided. The scale of such reasoned decisions should be commensurate with the weight of the issues in each case. When a new policy is being decided, a full explanation of the weight attached to all the issues would be entirely proper (as sometimes happens after consultation exercises have been evaluated). For routine releases a short letter, widely publicised, might be appropriate.
20. Together with strong, open scientific assessments, these proposals could help considerably to improve the quality of the debate on GMOs and ensure that the policy issues which arise are settled in ways which command the widest assent.

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