The
Precautionary Principle: risk, regulation and politics
Merton College, Oxford, 5-11 April 2002
Introductory Paper
by Dr Ragnar Lofstedt
written March 2002
1. Introduction
The precautionary principle has emerged as one of the
main regulatory tools of European Union environmental and
health policy with important ramifications for member
state policies. In addition, over the past 15 years, the
precautionary principle has increased in popularity
beyond European shores, underpinning a series of
international agreements such as the Convention on Bio-diversity.
Indeed, there have been no fewer than 14 multilateral
agreements citing the precautionary principle, ranging
from the 1992 UN Framework on Climate Change, to the 1994
Oslo Protocol on sulphur emissions, and the 1996 Syracuse
Amendment Protocol for the Protection of the
Mediterranean Sea against Pollution from Land-Based
Sources (Sand 2000). This is not to say that the
precautionary principle has been welcomed by all
governments' regulators. Indeed, it would be fair to say
that the use of the precautionary principle for
regulatory purposes is highly controversial. The
controversy now mostly relates specifically to European
policy, on which this paper focuses, but its
ramifications are of world-wide significance, as we shall
see at the conference.
The precautionary principle was arguably developed and originally implemented in Germany and Sweden, and it is these nations that remain the leading proponents of it. For example, it was one of these nations (Germany) that put the precautionary principle on the international stage, and today with regard to environmental regulation (in particular chemicals) it is Sweden that is pushing forward precautionary legislation in the European Union. There is a conflict between those who support the principle and those who oppose it. For example, American policy-makers have become increasingly concerned with the use of the concept by the EU, seeing it as a threat to scientific risk analysis as the main tool for regulation used hitherto. Academics in the United States point out that the US had precautionary elements in their regulations during the 1970s; but these elements turned out to be excessively costly and faulty, and so were abandoned following a Supreme Court judgment in 1980 (in an infamous case concerning benzene) which insisted that regulation must depend on scientific proof of risk. The whole discussion about when the precautionary principle should, and should not, be used has become so polarized that the EU felt it necessary to come forward with a so-called 'Communication' discussing this very issue and later a statement on it at the December 2000 Nice Summit.
As the precautionary principle grows in usage, the following issues arise which will be addressed in this introductory paper. Firstly, increased attention is being paid to what the precautionary principle actually means, as lawyers in particular find the concept ill-defined. Secondly, there is great concern about how invoking the precautionary principle causes conflict with science based risk analysis. Thirdly, there are the international implications of invoking the precautionary principle with regard to trade issues.
2. What is the precautionary principle?
a. Definitions
There is no one definition of the precautionary principle.
One Swedish author, Per Sandin, lists 19 formulations,
often individually vague and mutually contradictory.[1] The most
commonly used definition is contained in the 1992 Rio
Declaration:
In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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.
Another popular definition derives from an environmental meeting held in the United States in 1998 in Wingspread, Wisconsin. It states:
When an activity raises threats to the environment or human health, precautionary measures should be taken, even if some cause-and-effect relationships are not fully established scientifically. In this context, the proponent of an activity, rather than the public, should bear the burden of proof (of the safety of the activity).
One of the more rigorous analyses of the meanings of the precautionary principle have been put forward in work by Wiener and Rogers. They argue that there are three different formulations of the precautionary principle. These are:[2] (quoted in pages 4-5 in Wiener and Rogers, forthcoming)
Version 1: Uncertainty does not justify inaction. In its most basic form, the precautionary principle is a principle that permits regulation in the absence of complete evidence about the particular risk scenario. [Lack of full scientific certainty shall not be used as a reason for postponing measures to prevent environmental degradation-Bergen Declaration].
Version 2: Uncertainty justifies action. This version of the precautionary approach is more aggressive.
Version 3: Uncertainty requires shifting the burden and standard of proof. This version of the precautionary principle is the most aggressive. It holds that uncertain risk requires forbidding the potentially risky activity until the proponent of the activity demonstrates that it poses no (or acceptable) risk.
In the establishment of precautionary principles in Europe, Germany adopted version 1 while Sweden adopted version 3. When the precautionary principle was first discussed in international circles, version 1 was used under pressure from Germany, for example, with regard to protection of the North Sea:
Accepting that, in order to protect the North Sea from possible damaging effects of the most dangerous substances, a precautionary approach is necessary which may require action to control inputs of such substances even before a causal link has been established by absolutely clear scientific evidence.[3]
Indeed, when the principle was first introduced on the international stage, European officials saw little problem with implementing Version 1 of the precautionary principle, arguing that: 'Anticipatory standardization (is) essential for the development of new technologies [that] have infrastructure characteristics, so that companies will not invest against each other until one or more backs down.[4]
In sum, this early EU version of the precautionary principle, based on the German formulation, was considerably less risk averse than the Swedish one. However, as time went on the debate in the EU changed.
b. The precautionary principle today
As the precautionary principle has been increasingly used,
its public profile has become more and more controversial.
Many European industries view the precautionary principle
decreasingly as an acceptable risk management approach,
and increasingly as a tool for the more radical
environment and health advocates. These industries'
disenchantment is intensified both by less control over
interpretation of 'precaution' by regulatory bodies, and
by seeing the precautionary principle become a feature of
arguments employed by those with very different world
views. In these latter arguments precaution is seen as a
way to manage globalization and the so called 'risk
society', where risks extend over time and national
boundaries, without any right to compensation for many of
those affected by them.
The drivers of these changes include:
- Greater access to information, eg through the Internet, which can compete with established authority, allowing citizens unprecedented knowledge about government, industry, and research. As a result, risk management errors and scientific controversies are more visible at stages in the development of technologies when uncertainty is high.
- Regulators and industry have been at fault in connection with major health and environmental problems, leaving many stakeholders sceptical of regulators' motives and analytical procedures.
- As faith in professional risk managers has declined, the public has increasingly turned to NGOs, independent scientists, and the media for guidance. In Europe, Greenpeace has proven particularly effective, often invoking the precautionary principle.
Because of these developments, there is an increasing trend in the EU towards adopting a more far-reaching form of the precautionary principle, although it does vary from directorate to directorate and area to area within the European Commission itself, which further complicates matters. For example Article 7 of the new European Food Directive, published 22 February 2002, is still rather like version 1 of the principle when it states: '[In cases where the possibility of harmful effects on health have been identified] but scientific uncertainty persists, risk management measures...may be adopted, pending further scientific information for a more comprehensive risk assessment.'
However, if we look at the recent EU Chemical White paper (13 February 2001), it is more far-reaching:
Responsibility to generate knowledge about chemicals should be placed on industry. Industry should also ensure that only chemicals that are safe for the intended purposes are produced. The Commission proposes to shift responsibility to enterprises for generating and assessing data and assessing the risks of the use of the substances. The enterprises should also provide adequate information to downstream users.[5]
In other words in this document, the Commission is arguing for a completely reversed burden of proof (Version 3). Policy-makers, members of the Commission's Environment Directorate, environmental groups and some academics argue that the future of regulation in the EU will increasingly be toward version 3 of the precautionary principle.
3. Why is the precautionary principle so
controversial?
The debate is shrouded in discussions of promoting
sustainable development and coming to terms with
increased scientific uncertainty, but I see it as a
paradigm shift in regulation. If we look at the most far-reaching
definition of the principle - the version that
environmentalists, Swedish regulators and Green MEPs are
pushing through the EU at present, which at times is also
supported by Conservative MEPs as well as some trade
bodies - it represents a fundamental change of direction
away from past regulatory trends. Historically, in
several industrialized countries (in particular the
United States) the regulators had to use science to prove
that something was unsafe before industry took it off the
market. All industry had to do was inform the regulator
that they had produced a certain substance, describe to
the regulator what the substance was, and if the
regulator did not have an immediate concern, industry
would place it on the market.
Arguably, industry would have made sure that the substance was safe to both humans and environment, as it too did not want to put its customers at risk. Regulators, on the other hand, using scientific methods such as ecological toxicology (invoking mega-mouse experiments to see what the dose-response rate was), had to prove that the substance was unsafe. As such procedures were rather costly, regulators were never able to test every single substance (indeed over 90 per cent of all chemicals have not been tested by regulators), and hence have been relying on industry to ensure that they are safe. They also rely on the fact that, if it is not safe, industry will then be sued by unhappy customers. If the regulators did find something wrong with a certain substance, industry could challenge the regulator's findings in court. Indeed, William Ruckelshaus (then Chief Administrator of the US Environmental Protection Agency), argued that 80 per cent of its rulings against industry through the 1980's were challenged in court (although this figure has been questioned by some academics). In such an adversarial environment, there would be one set of government scientists on one side of the argument, with another set of industry scientists battling it out to prove to a US based judge/jury that their opponents were wrong. In some cases, industry actually used scientific arguments as a way to delay the passing of a regulation (known as paralysis by analysis); in others cases science was actually misused to support an argument, such as tobacco companies trying to prove that smoking is not addictive (leading to the use of labels such as 'tobacco science').
The precautionary principle is seen by some academics as a natural backlash against the approach to scientific risk analysis employed in the United States. They see it as costly and ineffective, leading to public distrust of authorities and scientists as a whole. They argue that invoking the precautionary principle shifts the locus of control from industry to regulators. Environmentalists and some academics, who support the principle, question the very notion of why regulators should need to prove something is safe. Why should industry not do this as industry created the substance in the first place? The companies know more about the substances than the regulators will ever do. In addition, the regulatory costs are then borne by industry and not regulators, which means that government regulatory costs can be reduced (one of the main reasons why the Swedes adopted version 3 of the precautionary principle). With the burden of proof reversed, industry is no longer in control, the regulators are. Basing their decisions not just on the science involved but also ethical and social concerns, the regulators can accept or reject the arguments from proof made by industry.
Of course, if we implement the reversed burden of
proof, the following questions arise:
- When is something safe? How safe is safe? Industry's definition of safe may be very different from what the regulators see as being safe. Who decides this? On what criteria are safety decisions made?
- Do we operate in a free market society or in a nanny state?
- Related to the above, what is uncertainty? Who defines uncertainty?
These questions will inevitably pose difficulties. For example, the regulators may be highly biased and put forward impossible environmental and public health criteria which industry will never be able to meet. Decisions may be made without consulting scientists, leading to what industry calls regulatory irrationality and emotionalism. The biggest issue relates to reduction in the capacity of industry to innovate and create. Industry needs predictability, it needs an understanding of what the regulatory environment is, and will be, in order to make properly well thought-out business decisions. If industry is not aware of what the regulatory boundaries are, it will be increasingly unwilling to take risks in developing a product that may then be rejected by the regulator, maybe owing to excessive emotionalism. Indeed, there is already an element of this in Sweden: some chemical industries are abandoning the Swedish market completely as they see the regulatory system being excessively costly with little benefit. For example, a pesticide producer may argue that the country only has 9 million inhabitants, and because of the cold and short growing seasons not that many pesticides are used anyway.
In contrast, proponents of the principle feel that by implementing it, industry will actually be forced to be more creative - that is, have to produce more environmentally friendly products - and point out that in nations where it has already been used, such as Germany and Sweden, industries are still able to make sound business decisions. In addition, most precautionary regulatory measures are based on some form of scientific risk assessment. For example, the Swedish Chemical Inspectorate's decision to not renew the licensing of anti-fouling paint products for pleasure boat owners operating in the Baltic Sea was based on a scientific study.[6]
The conundrum which we then face is what form of regulatory tool should be used and who should be responsible for its final implementation? As discussed earlier, a risk-based approach to regulation has on occasion been misused by industry, while a precautionary approach may be misused by environmentalists and other like minded individuals. The 'middle way' to avoid this problem was formulated in the EU's Communication on the precautionary principle - that is, risk assessment should be part of the principle - but there is as yet little evidence that this may actually work, or in fact has been attempted.
4. The precautionary principle and
international trade
One of the biggest areas of disagreement between the EU
and the US revolves around trade. With regard to health
and safety standards, the European Commission interprets
the Sanitary and Phytosanitary Standards (SPS) Agreement
in the light of the precautionary principle. That is to
say, it reaches the conclusion that the EU is in effect
able to pick and implement the level of safety that it
feels to be necessary, no matter what other nations may
say, without necessarily basing it on sound scientific
argument or risk analysis. This is something that the
eminent political scientist, Giandomenico Majone, refers
to as an 'isolationist stance.'[7]
Indeed, over the past ten years the EU has increasingly
used the precautionary principle to support various bans,
ranging from hormones in beef and milk to aflatoxins in
ground nuts, leading to accusations of protectionism from
the US and other trade blocs. For example, in 1985 what
was then the European Community banned all five growth
hormones based on consumer protection. At the time, the
EC Agriculture Commissioner Frans Andriessen, argued: 'Scientific
advice is important, but it is not decisive. In public
opinion, this is a very delicate issue that has to be
dealt with in political terms.' The US opposed the ban
arguing that there was no scientific basis and hence it
constituted an unwarranted obstacle to trade. The dispute
eventually led the US to impose retaliatory tariffs on EU
agricultural exports to the US. Finally, the US took the
EU to the WTO dispute panel, which concluded in 1997 that
the European ban was illegal.
Similar types of findings can be found in the other trade related disputes, eg over hormones in milk, in which a natural hormone Bovine Somatotropin, is injected into cows to increase milk yields - the EU originally banned it on social grounds, stating that there was no social or economic need for the product in Europe. In addition, with regard to the passing of very strict standards for aflatoxins in the name of the precautionary principle in the late 1990s, World Bank economists took the view that this would lead to a 64 percent reduction in the export of African crops to the EU, with a monetary worth of $700 million a year, in order to reduce deaths from liver cancer by possibly 1.4 deaths per billion a year.
Academics, US trade representatives and a wide range of stakeholders and policy-makers have asked whether these decisions were rightly based on the precautionary principle, or whether it was just a cover for trade protectionism. With regard to the three cases mentioned above, there was little scientific evidence for justifying the ban.[8] That is to say there was no proof (at least to date) that the products would cause undue harm to public health or the environment.
Hence, based on these findings some policy-makers and academics concluded that the EU is, in many circumstances, implementing the precautionary principle for the purpose of trade protectionism.
This may be a bit too simplistic. The EU has had a series of food scandals over the past 10 years or so, ranging from salmonella in British eggs, to dioxin in Belgian chicken feed, mad cow disease, and foot and mouth disease, making both consumers as well as regulators risk averse. However, this does not justify making a regulation on the basis of the precautionary principle, when in actual fact it is being made on the basis of public and regulator fear. It may have been better to have accepted these hormones and other substances on condition that they could be labelled once imported into Europe. (Indeed, US milk producers, who have decided not to use the Bovine Somatotropin hormone, are able to label their milk as hormone free, on condition that they also write on the label that to date this hormone is not known to cause adverse effects on humans). Likewise, other academics and policy-makers point out that it is not only the EU that takes precautionary measures which may have adverse affects on trade agreements. The United States can be accused of this as well. The US does not import unpasteurized cheeses from Europe as the nation's regulators are concerned about bacteria found in them, and, following the 'mad cow' outbreak, it no longer imports live animals from the EU. Wiener and Rogers argue that in actual fact both trade groups have invoked elements of the precautionary principle at some point or another (and continue to do so) for a wide array of social, cultural, environmental and health reasons.
5. So where do we go from here?
Arguably, the use of the precautionary principle will be
extended in Europe. This will continue to be opposed by
certain sectors of industry and American regulators for
the above-mentioned reasons. The real question is how
long these trends will continue. Or is this a permanent
paradigm shift? The political scientist David Vogel
argues that this may just be a trend.[9] That is to say, after 15
years or so, when the Europeans have figured out that
invoking the precautionary principle is simply too costly
and burdensome for industry, and on top of that hampers
innovation, the EU will follow along the lines of the
Americans and base their regulations on scientific risk
analysis. This perspective is based on a view that the
Europeans are always 20 years or so behind the Americans
when it comes to the regulatory cycle. Others point out
that in actual fact the precautionary principle reduces
not only regulatory costs, but also achieves a cleaner
environment at less cost for society,[10] and that hence the
precautionary principle should be invoked even more often.
It remains to be seen if Vogel or the EEA is right.
Suffice it to say, that the precautionary principle is
with us today, not only in Europe but in many other parts
of the world as well, owing to all the multilateral
agreements that have been made and will continue to be
made into the foreseeable future.
© 21st Century Trust
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Notes
[1] P Sandin, 'Dimensions of the precautionary principle' Human and Ecological Risk Assessment, Vol. 5(1999), n. 5, pp. 889-907.
[2] JB Wiener and MD Rogers, 'Comparing precaution in the United States and Europe', forthcoming in Journal of Risk Research, pp. 4-5.
[3] Second International Conference on the Protection of the North Sea, 1987, p. 7.
[4] Cited in KH Narjes, 'Europe - the technical challenge: a view from the European Commission' Science and Public Policy, vol. 16(1988), n. 6, p. 383-394.
[5] p. 8.
[6] RE Lofstedt, 'Risk and regulation: boat owners' perceptions of recent anti-fouling legislation', Risk Management and International Journal, Vol 3(2001), n. 3, p. 33-46.
[7] G Majone,'The precautionary principle and regulatory impact analysis', draft, 2001, p. 21.
[8] See D Vogel, Trading Up, (Cambridge, MA, 1995).
[9] D Vogel, 'The new politics of risk regulation in Europe', forthcoming in British Journal of Political Science, 2001.
[10] For example, European Environment Agency, Late Lessons from Early Warnings, (Copenhagen, 2001).
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