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Biotechnology Policy Debate

In September 2001 the European Commission published a consultation document, 'Towards a Strategic Vision of Biotechnology and Life Sciences', in order to solicit comments towards finalizing it.

'Policy Debate'

'Strategic Vision of Biotechnology': Introductory Note
In September 2001 the European Commission published a consultation document, 'Towards a Strategic Vision of Biotechnology and Life Sciences', in order to solicit comments towards finalizing it.

The full text and some comments can be found at http://europa.eu.int/comm/biotechnology/.

Comments from the OU’s Biotechnology Policy Group were among many which do not appear on that webpage, so we provide the text here.

COMMENTS from Biotechnology Policy Group

We welcome this consultation paper opening up biotechnology policy to the wider European debate. Our commentary focuses on Section 7 about risk regulation (specifically Section 7.1), by drawing upon our research recent on this theme. We raise three main issues.

1. Proportionate or precautionary regulation?

Over the last decade, European regulation has undergone a process of elaborating precaution – as a general principle, and as approaches used in specific cases. Such approaches have acknowledged the limits of the available scientific knowledge, and thus of 'science-based regulation'.

In the 'Strategic Vision' document, precautionary concepts co-exist uneasily with earlier models of 'science-based regulation'. In one place, the document refers to uncertainty and the need for precaution: 'Risk assessment should continue to be science-based and in cases where scientific evidence is insufficient, inconclusive or uncertain.... measures should be based on the precautionary principle.'

In another place, the document refers to identified risk: 'Community regulatory requirements should be proportionate and commensurate with the degree of identified risk....' (p. 20). This statement assumes that all risks are reliably identifiable (or even quantifiable) before regulatory requirements are set. Such an assumption excludes uncertainties which are not readily quantifiable.

Questions remain: How can novel hazards be identified before harm results? What uncertainties warrant more scientific knowledge than is currently available for regulatory decisions? What assumptions of the current knowledge should be tested empirically?

In order to keep such important questions open, the document should substitute a phrase from the Commission Communication on the Precautionary Principle: regulatory requirements should be 'proportional to the chosen level of protection' (CEC, 2000: p3).

2. No evidence of adverse effects?

Alongside the development of precaution, European regulation has undergone a debate on the criteria for evidence – e.g., how to identify hazards, how to test them, how to interpret the results, etc. However, often companies and governments have simply stated, 'There is no evidence of risk'. Such a statement begs the question of what efforts were made (and not made) to detect risks. Moreover, such statements have contributed to public distrust of risk regulation, especially since they are often contradicted by subsequent evidence of risk.

The 'Strategic Vision' document falls into that trap when it says: '... no peer-reviewed scientific evidence exists for any adverse effects to human health or the environment of the GMOs which have so far been authorised for marketing' (p.17). In practice, recent research has identified previously unknown pathways of potential harm. For example, since Bt maize was approved for commercial use, peer-reviewed experiments have shown that Bt toxin can harm non-target insect larvae through tritrophic effects; likewise through pollen exposure, a novel hazard previously unknown in plants. Harmful consequences for particular insect species in the field remain to be investigated.

Meanwhile scientific debate continues over how to interpret the available evidence. Public debate in turn responds to the 'sometimes contradictory nature of scientific information', as noted in the report of a Commission workshop (CEC, 1999).

Policy documents should avoid misleading statements such as 'there is no evidence of risk', and should instead acknowledge the often contradictory nature of scientific findings.

3. Common standards?

For research on risks of GMOs, it would be desirable for test methods and results to be comparable or complementary across Europe, as a basis for evaluating different interpretations of evidence. However, the 'Strategic Vision' document goes much further by mandating common standards, as if diversity were a problem: 'Common scientific and technical standards are essential for credible and authoritative science-based at the Community level' (p.20).

In the report of our EU-wide study of risk regulation, we documented how a drive for common standards marginalized or denied important issues in the 1990s. This drive contributed to a breakdown in the regulatory procedure and to public distrust of risk regulation. We recorded how some regulators tried to learn from this failure:

For Directive 90/220 the official problem was how to 'complete the internal market' by the harmonization of regulatory criteria. Specialist experts were expected to achieve a mutual recognition of risk assessments, or even uniform criteria across the EU. That 'technocratic' model led to an impasse, with the result that some regulators have been redefining the policy problem. They have sought to understand the diverse public concerns, to accommodate them through risk-assessment criteria, to broaden the definition of 'adverse effects', and to introduce further precautions (OU BPG, 2000).

As that experience shows, there are legitimate reasons for different standards of various kinds – e.g., in selecting causal pathways for science to investigate, in designing safety tests, in evaluating the results for predictions of harm, in interpreting all the results for risk assessment, and in deciding whether plausible effects are acceptable. While comparable or complementary test methods and results are desirable, forcing common standards suppresses legitimate reasons for differences, thus exacerbating mistrust of the regulatory process and risk assessment.

As regards scientific expertise, a drive for consensus suppressed differences in the 1990s. EU-level advisory committees based their opinions on a single standard of environmental harm and of evidence, as if it were the only possible basis for 'science-based regulation'. However, risk-assessment advice cannot be value-neutral; it is inseparable from risk-management judgements, agro-environmental norms, and thus the public debate (OU BPG, 2000).

Therefore the value basis of risk-assessment judgements should be openly acknowledged.

Conclusion

Summarizing the three main points above, we recommend that regulatory policy should:

1. base regulatory requirements on the chosen level of protection – e.g., on unacceptable harm, not simply on identified risk;

2. emphasize what uncertainties have (and have not) been tested, rather than make claims about the absence of evidence of adverse effects; and

3. encompass diverse standards for evidence, as well as diverse viewpoints within official expert bodies, rather than pursue a technocratic form of harmonization.

For more detail on these points, we refer readers to the report of our recent project, as listed below.

References

CEC (1999) GMO Research in Perspective, report of a workshop, Sept 1999

CEC (2000) Communication from the Commission on the Precautionary Principle, February 2000, http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf

OU BPG (2000) 'Safety Regulation of Transgenic Crops: Completing the Internal Market?', Milton Keynes: Open University, Biotechnology Policy Group, http://technology.open.ac.uk/cts/srtc/

Comments submitted by Susan Carr, Les Levidow, David Wield
Biotechnology Policy Group, 14 November 2001

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