5 Precaution, risk and uncertainty
96. In attempting to better understand the reasons
for the current EU regulatory situation with regard to genetically
modified organisms (GMOs), we paid particular attention to the
way in which the precautionary principle had been interpreted
and applied. Speaking in general terms, the Government Chief Scientific
Adviser, Professor Sir Mark Walport, told us that he was "afraid"
that:
the precautionary principle has been used as
a method of putting a red stop light in front of innovation rather
than recognising that innovation is something where you need to
consider both the benefits and risks. Sometimes there may be an
amber light and it may be necessary to collect more evidence;
on other occasions it may be that the balance of not doing something
is worse than doing something.[329]
In this chapter, we explore the extent to which Sir
Mark's characterisation of the precautionary principle as a potential
barrier to innovation is justified and consider how the balance
between precaution and innovation might be better managed.
EU GMO regulation: a misuse of
the precautionary principle?
97. As was previously described (see paragraphs 49-51),
the precautionary principle is generally considered to have played
a significant role in informing the current EU regulatory framework
for genetically modified organisms. This framework was initially
developed in the 1990s, at a time when, according to the Royal
Society, there was "an absence of evidence of whether GMOs
posed different or greater risks to human health and/or the environment
than organisms developed using existing methods".[330]
However, it stated that "our understanding of genomes and
experience of using GM crops has expanded considerably" since
then and added that, "where risks have been identified",
they have been shown to "relate to the trait that has been
introduced rather than the method by which it was introduced".[331]
It added:
the consensus of scientific bodies is that the
scientific evidence no longer justifies the precaution of controlling
organisms specifically because they were generated using
recombinant DNA technology.[332]
Professor Joyce Tait, Innogen Institute, agreed that
while precaution may have been justified "when we were first
considering how to regulate GM crops", when "we did
not have very much information about their risks and benefits",
it would now "be very reasonable to relax the precautionary
principle and make the regulatory system adaptive in the context
of the new knowledge we now have about GM crop development".[333]
GM Freeze, however argued that the EU's precautionary approach
to GMO regulation remained "entirely appropriate because
a number of negative effects have been identified", including
"the documented environmental impact of planting Roundup
Ready crops, and other effects for which it is not currently possible
to evaluate either the likelihood or impact to an acceptable level
of certainty".[334]
Professor Paul Nightingale, University of Sussex, agreed that
the principle was "being properly applied" in the case
of GMOs because "the conditions for its application are met":
that is, scientific uncertainty and the potential for serious
and irreversible harm.[335]
98. In attempting to unpick these arguments and establish
whether or not continued recourse to the precautionary principle
is appropriate for all products generated via genetic modification,
we drew on the European Commission's own 2000 Communication
on the topic, which aims to establish guidelines for the principle's
application. This document stresses that "the implementation
of an approach based on the precautionary principle should start
with a scientific evaluation" and that recourse to the principle
"presupposes that potentially dangerous effects deriving
from a phenomenon, product or process have been identified".[336]
It stipulates that "the precautionary principle can under
no circumstances be used to justify the adoption of arbitrary
decisions" and that subsequent risk management measures "may
not be of an arbitrary nature".[337]
The European Commission does not precisely define the precautionary
principle in this document; however, it stipulates its relevance
to:
those specific circumstances where scientific
evidence is insufficient, inconclusive or uncertain
and there are indications through preliminary objective scientific
evaluation that there are reasonable grounds for concern
that the potentially dangerous effects on the environment,
human, animal or plant health may be inconsistent with the chosen
level of protection.[338]
[Emphasis added.]
99. The evidence that we have detailed elsewhere
in this report enables us to demonstrate that not one of these
requirements continues to be universally met for crops produced
via genetic modification. Taking these in turn:
· As we have previously concluded, the weight
of scientific evidence collected over many years demonstrates
that the premise that genetically modified crops pose greater
risk than their conventional counterparts is unjustified (see
paragraph 61-62). We are satisfied that the scientific evidence
relating to the use of genetically modified crops is neither insufficient,
inconclusive nor uncertain.
· We have also concluded that any risk that
genetically modified crops have been shown to pose derives from
the trait displayed rather than any inherent risk posed by the
technology itself (see also paragraph 63-64). In other words,
objective scientific evaluation has provided no indication
that there are reasonable grounds for concern that these
products might lead to potentially dangerous effects on
the environment, human, animal or plant health.
· Society has indicated, through its use
of other technologies posing comparable risk, (for example, non-GM
herbicide tolerant crops), that it considers the level of risk
posed by genetically modified organisms to be acceptable (see
paragraph 63). That is, the risk posed is not inconsistent with
society's chosen level of protection
According to Dr Mike Bushell, Syngenta, "what
we are seeing in many cases is not the application of the precautionary
principle as defined in the Commission's own documents, but actually
a smokescreen of uncertainty being put around technology to stop
it happening for politically motivated reasons".[339]
100. We agree
with the European Commission that a precautionary approach is
appropriate in circumstances where scientific evidence is insufficient,
inconclusive or uncertain and when there is reason to believe
that potentially dangerous effects on the environment, human,
animal or plant health might result if precaution is not exercised.
However, it is clear from the evidence that we have received that
these conditions are not met simply because a crop has been produced
via genetic modification. Continued recourse to the precautionary
principle in relation to all genetically modified crops is therefore
no longer appropriate. Indeed, it has acted as a barrier to progress
in this field.
101. The European Commission's Communication on the
precautionary principle states that "reliance on the precautionary
principle" is "no excuse for derogating from the general
principles of risk management".[340]
It lists these as:
· Proportionality,
which requires that "measures based on the precautionary
principle must not be disproportionate to the desired level of
protection and must not aim at zero risk";
· Non-discrimination,
which requires that "comparable situations should not be
treated differently and that different situations should not be
treated in the same way, unless there are objective grounds for
doing so";
· Consistency,
according to which "measures should be consistent with the
measures already adopted in similar circumstances or using similar
approaches"'
· Examination of scientific developments,
followed by re-examination and modification of precautionary measures
as appropriate; and
· Examination of the benefits and costs
of action or lack of action, from both
economic and wider societal perspectives.[341]
Our work during this inquiry strongly suggests that
these requirements are not being met in the case of GMO regulation.
We have already referred to the strong scientific consensus regarding
the comparative safety of existing GMO products relative to their
conventional counterparts. In light of this, several witnesses
considered the current regulatory regime to be both "disproportionate"
and inflexible to scientific developments.[342]
Witnesses also pointed out the rigorous risk assessment required
for GMOs compared with other plant technologies (for example,
non-GM herbicide-tolerant crops)[343]
and the stringent risk management measures applied to these products
compared with other comparable products (for example, pesticides).[344]
This suggests a breach of the principles of both non-discrimination
and consistency. The failure of the current regulatory system
to take into consideration the benefits of action or costs of
inaction was also frequently highlighted (see paragraph 72-74).
102. There are
vast discrepancies between the European Commission's stated approach
to applying the precautionary principle and its adoption in practice.
Uncertainty about how the principle is being used at EU level
is not helped by the lack of a consistent definition. We
recommend that the European Commission consult with stakeholders
in order to update its 2000 'Communication' on the precautionary
principle. The updated document should include a clear definition
of the principle and should stipulate the necessary conditions
for it to be used as a basis for EU policy. In future, when the
European Commission draws upon the precautionary principle in
its policy making, it should publicly state: a) how the controlled
activity meets its specified conditions for recourse to the precautionary
principle; b) how measures adopted in response align with the
general principles of risk management (described above), and c)
what is being done to resolve uncertainties and render continued
precautionary measures unnecessary.
103. We remind the Commission that any legislation
guided by the precautionary principle must allow for an exit from
precautionary measures once there is strong scientific consensus
that any risks are low.
Responding to uncertainty
104. As the above evidence indicates, Sir Mark's
claim that the precautionary principle has, in some instances,
acted as "a red stop light in front of innovation" appears
to be borne out in the case of EU GMO regulation.[345]
In part, this appears to be due to a lack of clarity and consistency
in its interpretation and application. However, appropriate use
of the precautionary principle also appears to be confounded by
another factor: a blurring of scientific and other forms of uncertainty.
105. As previously stated, in 2005 the UN World Commission
on the Ethics of Scientific Knowledge and Technology described
the precautionary principle as the belief that:
When human activities may lead to morally unacceptable
harm that is scientifically plausible but uncertain, actions shall
be taken to avoid or diminish that harm.[346]
This definition, like several others,[347]
hinges on the presence of scientific uncertainty. However,
even when scientific uncertainty has been largely resolved, other
forms of uncertainty can remain. According to Professor Andy Stirling,
University of Sussex, value-based uncertainties—or "ambiguities"—can
arise "even for events that are certain or have occurred
already": in the case of genetically modified foods, for
example, "ambiguities arise over ecological, agronomic, safety,
economic or social criteria of harm", which are independent
of scientific questions of relative risk.[348]
Several witnesses argued that the EU's use of the precautionary
principle had been driven by political concerns associated with
these areas of ambiguity rather than by genuine scientific uncertainty.
Dr Julian Little, Agricultural Biotechnology Council, referred
to the case of maize 1507 (see box 5), in which he argued that
the precautionary principle had been used to undermine science-based
risk assessment "as a way of stopping this [product] getting
to the market".[349]
Dr Paul Burrows, Biotechnology and Biological Sciences Research
Council, stated that "if the [European] Commission is applying
the precautionary principle" to genetically modified crops,
then "personally, I do not think it is applying it because
of the science".[350]
The Government and its Chief Scientific Adviser appeared to have
similar concerns. Sir Mark stated that the principle had
become "politicised with a small 'p'" and the Minister
agreed that "the idea of precaution" was being "misused
to block or deter innovations such as GM, which are politically
controversial" and that the EU's "misuse of the precautionary
principle" was "one instance" of "a poor approach
to the formulation and implementation of science-based regulation".[351]
106. The evidence that we received suggested that
the source of uncertainty about a given technology—and the
extent to which it is science-based, as opposed to value-based—is
key to establishing whether or not continued recourse to the precautionary
principle is appropriate.[352]
According to the Science Council:
The precautionary principle is […] usefully
applied when there remains uncertainty or no scientific consensus
about the level of risks around a product or process. But when
there is strong scientific consensus that the same product or
process is considered to be low-risk then the precautionary principle
is logically obsolete.[353]
Professor Stirling stated that the precautionary
principle "comes into its own" under those "more
intractable states of incertitude" where risk assessment
is unable to provide a rational basis for decision-making.[354]
While risk assessment can be a valid response to scientific uncertainty,
Professor Stirling argued that it was "misleading to claim
that single definitive science-based decisions"—such
as those derived from risk assessment—were possible in such
situations and suggested that other approaches, such as "substantive
public engagement", offered an alternative approach to understanding
and responding to these types of uncertainties.[355]
107. Several other witnesses also highlighted the
importance of public engagement as an alternative response to
uncertainty. The Royal Society stated that "public and stakeholder
dialogue should be a part of all" risk governance frameworks
and Sir Roland Jackson, Nuffield Council on Bioethics, agreed
that "public engagement and […] wider stakeholder engagement"
had "quite a role to play".[356]
In its recent report on Emerging biotechnologies, the Nuffield
Council on Bioethics also strongly emphasised the moral value
of public discourse. According to this report, the "significant
public interest" arising from emerging biotechnologies (such
as advanced genetic breeding techniques) means that they should
be subject to a "public ethics", based on securing public
good, rather than a more "individualistic ethics that attempts
only to protect the freedoms of individuals in ways compatible
with the freedom of others within a society".[357]
The report argued that, while "in a plural society there
will not be a single vision of the public good that can be applied
in all circumstances", the construction of a public discourse
based on certain procedural and institutional virtues[358]
could offer a "practical way of responding collectively"
to the challenges posed by emerging biotechnologies through "'public'
decision making, orientated by pursuit of the public good".[359]
108. Various models intended to more formally incorporate
public and stakeholder engagement into the risk analysis process
have been developed. One of these is the International Risk Governance
Council's Risk Governance Framework, which modifies the
traditional three-stage risk analysis process (risk assessment,
risk management, risk communication) to include two additional
stages: "risk pre-assessment", in which different potential
framings of the problem are considered, and "characterisation
and Evaluation", in which scientific data are considered
alongside societal factors in order to evaluate whether the risk
is "acceptable, tolerable (requiring mitigation), or intolerable
(unacceptable)".[360]
Professor Joyce Tait, Innogen Institute, described this framework
as "quite an advanced approach to looking at these kinds
of questions where value judgment comes into play".[361]
Similarly, the final report of the EU-funded Safe Foods Initiative
offered a structured approach to the assessment and management
of food safety threats in which framing and consideration of societal
factors played a more formalised role than is typical in current
approaches.[362]
109. We have
already acknowledged the considerable relevance of societal concerns
to decision-making about risk and reiterate the need for non-scientific
factors to be considered alongside scientific risk assessment
during the risk governance process. However, the precautionary
principle was designed primarily as a response to scientific uncertainty,
not value-based ambiguity. Such ambiguities are common in emerging
areas of science and technology and are also often intractable;
recourse to the precautionary principle in these scenarios would
therefore potentially act as a permanent barrier to the use of
safe innovations. Where value-based ambiguities exist, public
discourse, not scientific risk assessment, should be pursued as
a route to greater legitimacy.
110. We recommend that the Government give greater
consideration to the value that participatory processes might
contribute to its own treatment of risk and uncertainty in policy
development. We particularly refer the Government to the Risk
Governance Framework and Safe Foods Initiative and ask it to set
out how the perspectives offered by these documents will inform
its future approach to risk governance policy. The next chapter
gives further consideration to the subject of public information
and discourse.
Government use and interpretation
of the precautionary principle
111. Our interpretation of the precautionary principle
is broadly in line with both the stated position of the European
Commission (see paragraph 95) and that of the UN's World Commission
on the Ethics of Scientific Knowledge and Technology, which stipulates
that the principle should be applied where the risk of "morally
unacceptable harm" is "scientifically plausible but
uncertain".[363]
However, the Government Chief Scientific Adviser, Professor Sir
Mark Walport, offered a somewhat different interpretation. In
an April 2013 opinion piece in the Financial Times, Sir
Mark framed the precautionary principle not as a response to scientific
uncertainty, but as a guide to evidence-based decision-making.
According to Sir Mark:
Decisions must be informed by the best evidence
and expert advice. The application of the "precautionary
principle" can help to guide this. This simple idea just
means working out and balancing in advance all the risks and benefits
of action or inaction, and to make a proportionate response. All
too often, people citing this principle simply overreact: if there
is any potential hazard associated with an activity, then it should
not be done, or, if it is already being done, it should be stopped.[364]
Sir Mark described the precautionary principle to
us in similar terms during this inquiry, stating that the principle
"basically" means: "Do a full evaluation of the
science before you make a decision" and "think about
the consequences of both action and inaction".[365]
The Minister stated that he "broadly agree[d]" with
this definition and, like Sir Mark, stressed that the principle
required that "a full science-based evaluation" be carried
out before a decision be made.[366]
In his first annual themed report, Innovation: managing risk,
not avoiding it, Sir Mark expressed concern about an apparent
"drift of interpretation of the precautionary principle from
what was, in effect, a holding position pending further evidence,
to what is now effectively a stop sign".[367]
However, despite focusing heavily on the subjects of innovation,
risk and uncertainty, this report contained no specific recommendations
about how the principle might be more systematically applied.
112. Sir Mark's argument that the precautionary principle
requires "all the risks and benefits of action or inaction"
to be "work[ed] out and balanc[ed] in advance"[368]
could be seen to vary significantly from those definitions that
place the existence of scientific uncertainty at their centre.[369]
In a chapter in the supporting case studies for Sir Mark's annual
themed report, Professor Andy Stirling, University of Sussex,
stated that although the precautionary principle "comes in
many forms, a classic general expression of precaution is that
scientific uncertainty is not a reason for inaction in preventing
serious damage to human health or the environment".[370]
He continued:
By explicitly hinging on uncertainty rather than
risk, precaution helps to promote recognition that social choices
in innovation are not reducible to ostensibly precise, value-free,
technical risk assessments.[371]
In another 2013 opinion piece, commentator George
Monbiot criticised Sir Mark for his "misunderstanding of
the precautionary principle"—a concept that he considered
to be "fundamental to Walport's role" as Chief Scientific
Adviser.[372] He rejected
Sir Mark's focus on scientific evaluation and compared this with
the definition of the precautionary principle offered by the Rio
Declaration:
where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be used as
a reason for postponing cost-effective measures to prevent environmental
degradation.[373]
Science policy experts Professor Roger Pielke Jr
and James Wilsdon defended Sir Mark against Monbiot's claim that
he had "misinformed the public about the scientific method,
risk and uncertainty",[374]
but stated that it was "fair to criticise Walport for a rather
lazy caricature of the precautionary principle".[375]
113. The Government
recognises the importance of properly understanding and applying
the precautionary principle, but it is not clear that it has done
so. Government explanations emphasise the need for decisions made
under the guidance of the precautionary principle to be based
on a "full science-based evaluation", but fail to recognise
that such evaluations are often impossible in those circumstances
when precaution is most needed—that is, in situations of
scientific uncertainty or ignorance. The Government Chief Scientific
Adviser's first annual themed report, on the subject of innovation
and risk, has done little to clarify this situation. The
Government should prepare a short document, informed by wider
consultation, detailing its understanding of the principle and
the circumstances in which it intends to use the precautionary
principle as a guide to policy making. This should be made publicly
available by the end of 2015.
329 Q288 Back
330
GMC044 [Royal Society] para 20 Back
331
GMC044 [Royal Society] para 21 Back
332
GMC044 [Royal Society] para 21 Back
333
Q220 [Professor Tait] Back
334
GMC020 para [GM Freeze] 1.5 Back
335
GMC045 [Professor Nightingale] para 33 Back
336
European Commission, Communication from the Commission on the
precautionary principle, COM(2000)1, February 2000, p.4 Back
337
European Commission, Communication from the Commission on the
precautionary principle, COM(2000)1, February 2000, p.13 Back
338
European Commission, Communication from the Commission on the
precautionary principle, COM(2000)1, February 2000, p.10 Back
339
Q187 [Dr Bushell] Back
340
European Commission, Communication from the Commission on the
precautionary principle, COM(2000)1, February 2000, p.18 Back
341
European Commission, Communication from the Commission on the
precautionary principle, COM(2000)1, February 2000, para 6.3 Back
342
See, for example, GMC037 [ADHB] para 9, GMC029 [SCIMAC] exec
summary, GMC027 [Professor Baulcombe] para 3 and GMC013 [Professor
Pollock] exec summary Back
343
See, for example, Q418 [Professor Hails]; Q22 [Professor Leyser] Back
344
See, for example, Q318 [Professor Perry] Back
345
Q288 Back
346
United Nations Educational, Scientific and Cultural Organization,
World Commission on the Ethics of Scientific Knowledge and Technology,
The Precautionary Principle, March 2005, p.14 Back
347
For example: that of the European Commission (precaution is appropriate
in "those specific circumstances where scientific evidence
is insufficient, inconclusive or uncertain", see paragraph
96), the Rio Declaration ("lack of full scientific certainty
shall not be used as a reason for postponing cost-effective measures
to prevent environmental degradation"), the Cartagena Protocol
on Biosafety (which draws on the Rio definition), and the UN Framework
Convention on Climate Change ("where there are threats of
serious or irreversible damage, lack of full scientific certainty
should not be used as a reason for postponing" measures to
"anticipate, prevent or minimise the causes of climate change
and mitigate its adverse effect"). Back
348
Andrew Stirling "Risk, precaution and science: towards a
more constructive policy debate", EMBO reports, vol
8 (2007), pp.310 Back
349
Q187 [Dr Little] Back
350
Q165 Back
351
Q291; Q471; GMC051 [Gov] para 38 Back
352
See also Andrew Stirling "Risk, precaution and science:
towards a more constructive policy debate", EMBO reports,
vol 8 (2007), pp.309-315 Back
353
GMC047 [Science Council] para 5.4 Back
354
Andrew Stirling "Risk, precaution and science: towards a
more constructive policy debate", EMBO reports, vol
8 (2007), pp.312 Back
355
Andrew Stirling, "Opening Up the Politics of Knowledge and
Power in Bioscience", PLoS Biology, volume 10 (2012),
p.4 Back
356
GMC044 [Royal Society] para 5; Q227 [Sir Roland Jackson] Back
357
Nuffield Council on Bioethics, Emerging biotechnologies: technology,
choice and the public good, December 2012, para 17; executive
summary, chapter 4 overview Back
358
The report defined these virtues as openness and inclusion, accountability,
public reasoning, candour, enablement and caution. Nuffield Council
on Bioethics, Emerging biotechnologies: technology, choice
and the public good, December 2012, para 23 Back
359
Nuffield Council on Bioethics, Emerging biotechnologies: technology,
choice and the public good, December 2012, para 23; executive
summary, chapter 4 overview Back
360
International risk governance council, 'IRGC risk framework',
irgc.org, accessed 26 January 2015. Back
361
Q258 [Professor Tait] Back
362
Marion Dreyer, Ortwin Renn, Adrian Ely, Andy Stirling, Ellen
Vos and Frank Wendler, 'A General Framework for the Precautionary
and Inclusive Governance of Food Safety in Europe', Final Report
of subproject 5 of the EU Integrated Project SAFE FOODS, June
2008. Back
363
United Nations Educational, Scientific and Cultural Organization,
World Commission on the Ethics of Scientific Knowledge and Technology,
The Precautionary Principle, March 2005, p.14 Back
364
"There is no easy solution to the problem of the bees",
Financial Times, 26 April 2013, accessed 26 January 2015. Back
365
Q288 Back
366
Q471 Back
367
Government Office for Science, Innovation: managing risk, not
avoiding it, Annual Report of the Government Chief Scientific
Adviser, November 2014, p.8 Back
368
"There is no easy solution to the problem of the bees",
Financial Times, 26 April 2013, accessed 26 January 2015. Back
369
For example, that of the United Nations World Commission (paragraphs
49), the European Commission (paragraph 95) Back
370
Government Office for Science, Innovation: managing risk,
not avoiding it, Evidence and Case Studies, 'Chapter 4: Making
choices in the face of uncertainty: strengthening innovation democracy',
November 2014, p.59. Back
371
Government Office for Science, Innovation: managing risk,
not avoiding it, Evidence and Case Studies, 'Chapter 4: Making
choices in the face of uncertainty: strengthening innovation democracy',
November 2014, p.59. Back
372
"Beware the rise of the government scientists turned
lobbyists", Guardian Online, 29 April 2013, accessed
26 January 2015. Back
373
"Beware the rise of the government scientists turned
lobbyists", Guardian Online, 29 April 2013, accessed
26 January 2015 Back
374
"Beware the rise of the government scientists turned
lobbyists", Guardian Online, 29 April 2013, accessed
26 January 2015 Back
375
"Why Monbiot's attack on Walport misses the mark",
Guardian Online, 30 April 2013, accessed 26 January 2015 Back
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