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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