Comments on: A Canadian Perspective on the Precautionary Approach/Principle
By Stuart Lee, Ph.D. and Katherine Barrett, Ph.D.
University of Victoria & Science and Environmental Health Network - March 28, 2002
In the fall of 2001, the Government of Canada released a Discussion Document on the interpretation and implementation of the precautionary principle/approach. This document aims to clarify and formalise Canada's position on the precautionary principle.
The following report was prepared in response to a call by the Canadian government for public comments on the Discussion Document. We focus our comments on the implications of adopting a limited definition of "sound science". We then outline several practical steps for implementing an effective and non-arbitrary precautionary principle.
Summary of Comments
The Canadian government is taking a courageous and well-needed step forward in explicitly addressing the issue of the precautionary principle. This is well-needed because the sentiment expressed by the principle is gaining in popularity world-wide and has been included in a number of key international and domestic agreements to which the Federal Government is signatory. This is courageous because the precautionary principle is highly controversial and has come under attack from trade-related and other sectors. The Discussion Document is just the kind of open, participatory process that we believe is consistent with implementation of a precautionary approach.
Our comments are structured into four parts. The first part discusses a number of critical issues arising from potentially problematic assumptions embedded in the document. Our analysis focuses primarily on the role of science and research as it is proposed in the Discussion Document. In the second part we recommend how to address or at least differently approach these problems by including a sociological analysis. The third part is an excerpt from a recent article by one of the authors (Barrett) that addresses the challenge of implementing the precautionary principle. In the final part, we explicitly answer several of the questions posed in the Discussion Document.
Part 1 – Analysis of the Discussion Document
- The Role of Science
On the whole, the Discussion Document is informative and fair-minded. It is particularly significant that the precautionary principle is recognised as a "legitimate and distinctive decision-making tool" (p14). However, we suggest that the precautionary principle need not be subsumed under the rubric of risk management (see Part 3 of our comments).
Despite the significant contributions of the Discussion Document, we argue that it contains inconsistencies and unarticulated assumptions that seriously reduce the effectiveness of the proposed framework.
Most glaringly, the document is inconsistent about the role of science in the precautionary principle and in policy-making in general.
In some sections of the report, "science" is portrayed as one (albeit important) component of decision-making which must be balanced with other social values and perspectives, and must be recognised as inherently uncertain and controversial.
Some sections of the Discussion Document acknowledge the inherent limitations of science and imply that science is but one component of decision-making.
This approach is consistent with Industry Canada's Principles and Guidelines for the Effective Use of Science and Technology Advice in Government Decision Making ("Guidelines") which state that scientific advice should be "one input in government decision making" (Guidelines p.2, emphasis added). The Guidelines elaborate on this point by stressing the importance of "getting conflicting viewpoints on the table" (Guidelines p.5), by suggesting that advisors from "not necessarily scientific disciplines" (Guidelines p.6) should be included on advisory panels, and by stating that "government must consider a wide range of other inputs (including traditional knowledge, ethical and cultural considerations, etc.) (Guidelines p.2).
We notice that throughout much of the introductory text, the Discussion Document follows these Guidelines, for example by:
- including multiple and diverse points of view "from a variety of scientific sources and experts from many disciplines" (Discussion Document p.6)
- clearly stating that judgment is required to determine what constitutes a sufficiently sound or credible scientific basis (Discussion Document p.5)
- including empirical, theoretical and traditional knowledge (Discussion Document p.5) in the definition of "sufficiently sound scientific information".
- acknowledging that scientific uncertainty is, in some cases, irreducible or "quasi-permanent" (Discussion Document, p.17) and that it "may take a long time to resolve or may never, for practice purposes, be resolved to any significant degree" (Discussion Document, p.6).
These statements suggest that that scientific information, while necessary and important, should not be relied upon as the sole basis for decision-making. These are important admissions that solidly ground the Discussion Document in line with conclusions from recent socio-scientific controversies.
In contrast, the proposed Principles for Application and Principles for Precautionary Measures imply that scientific information can and should be the "final arbiter" in determining precautionary measures.
Some examples of this position are:
Principle 3.2 "… in all cases sound scientific evidence is a fundamental prerequisite to applying the precautionary principle."
Principle 3.3 "Sound scientific information and its evaluation must be the basis for applying the precautionary approach… A valid and reasonable scientific information base underpins the application of the precautionary approach."
Principle 3.4 "The scientific evidence required [for decision making] should be established relative to the chosen level of protection."
These principles appear to contradict the important statements made in the introductory section of the Discussion Document and run counter to the advice given in Industry Canada's Guidelines. As currently worded these principles inappropriately imply that:
- The definition of sound science is predetermined and universal
- Sound science is possible and appropriate even under highly uncertaint conditions
- Science can be separated from "judgment, values and priorities".
The contradictory relation between these Principles and the broader Discussion Document creates an ambiguous and ineffective characterization of the role for science in the precautionary principle and in policy-making more generally.
We suggest that, if the guiding principles are to be used as a stand-alone document, all reference to "sound science" or "scientific evidence" be qualified by explicit reference to, and inclusion of the qualifications set out in Section 2.1 of the Discussion Document.
Our reasons for this recommendation are further elaborated in Part 2 below.
- Relationship of the Precautionary Principle to Innovation and Trade
The Discussion Document (and the Integrated Risk Management Framework upon which the Document draws) contain some questionable assumptions about the relationship of the precautionary principle to innovation and trade.
Innovation is not threatened by the precautionary principle.
The Discussion Document notes the importance of ensuring that "the precautionary approach is not used as an unnecessary or unintentional barrier to innovation or technological change (p.18). Similarly, the Integrated Risk Management Framework notes that innovation and risk-taking frequently can co-exist. Neither document, however recognises that precaution and innovation can and often do co-exist. In fact, positioning precaution against innovation contradicts the original meaning of the precautionary principle which called for forward planning, action, and care to foresee and prevent harms before they occur. The rhetoric that pits the precautionary principle against innovation in the Discussion Document should be omitted, and the opportunities for innovation afforded by precaution should be explored (see Part 3.7 below).
"Least trade restrictive" measures should be excluded from the proposed general principles.
"Least trade restrictive" measures have no place in guiding implementation of the precautionary principle. Primarily, such qualifications on decision-making tend to subordinate environmental, social, and cultural factors to the least common denominator of "harmonised" trade agreements.
Furthermore, "least trade restrictive" clauses can force unwieldy, expensive solutions, and be used to distribute the burden of bearing costs disproportionately onto governments. As noted in the Methanex case, they can be interpreted in such a way as to unduly affect policy making.
For these reasons, we suggest that the relationship between trade and precautionary procedures be determined, when appropriate, on a case-by-case basis.
Follow-up research approaches must be flexible.
Scientific knowledge is very expensive. Good science often requires a strong supporting bureaucracy for monitoring, modelling, assessment and knowledge management. Although follow-up research and social learning are important and achievable on a domestic scale, we must be cautious when introducing mandatory and harmonised scientific requirements globally. Not all nations can be expected to generate and nurture the infrastructure and personnel necessary to monitor every potential harm. A degree of flexibility is required for these situations.
Part 2 – Recommendations
We suggest that the above problems arise in part from an under-theorised account of the sociology of science. That is, science should be recognised as an inherently and necessarily social process that cannot be separated from other "social values".
The following points should be considered in regards to the role of science in the precautionary principle and in policy-making more generally.
The above points suggest that it is problematic to base a policy framework on the assumption of a pre-determined or universal standard of "sufficiently sound science". Rather, the intellectual and policy challenge lies in making decisions in an environment where reliable prediction is impossible, and the likely effects of a new activity are often beyond our ability to monitor or control.
- A "science-based approach" is a social value. The turn to science to solve problems or to provide justification for decision-making must be acknowledged as a social and value-laden activity. Science is guided by judgement, values and priorities. These elements of human activity are present in the experimental design, analysis of data, choice of figures to present, and in the types of questions which are posed. Thus, the distinction between scientific knowledge and other "social values" is indefensible intellectually and unhelpful politically. Choosing a "science-based" approach is a social value and should be recognised as such.
- "Sound science" is attributed at the end of a controversy. Sociological studies have aptly demonstrated that scientific research alone is unlikely to bring closure on a given issue. Case studies of regulatory and legal controversies persuasively argue that the label "sound science" is the outcome of a protracted political struggle, rather than a predetermined feature of a certain type of scientific study. Often, non-scientists, such as judges or trade lawyers, attempt to make the final determinations of what or whose science is sufficiently "sound", but in the end, this is a judgment of history that cannot always be well forecast.
- The politicisation of "sound science" is inevitable. Particularly in cases where the precautionary principle is invoked, there are likely to be credible scientific experts on both sides of the dispute. Attempting to settle such scientific disputes invariably involves politics, values and judgements. These factors should not be buried in the search for an "objective" science, but should be made an explicit part of the decision-making process.
- Risks and benefits are often unknown and unevenly distributed. Because the precautionary principle is invoked in situations of high uncertainty, the relative risks and benefits of a decision are often difficult or impossible to calculate accurately. Nonetheless, it should be recognised that ultimately, particular individuals or populations will bear these risks, while often others reap the benefits. It is necessary to consider this distributive aspect of risk management and the precautionary.
We therefore suggest that implementation of the precautionary principle be focused on designing and implementing a process that emphasises and draws upon heterogeneous, conflicting and partial perspectives. This process should foster public input and deliberation on the appropriate role of science and other factors in decision-making and must strive to make explicit the values which frame, define and fund public policy decisions.
Undoubtedly this process will have limitations due to, for example, financial constraints, political pressures, availability of data, and, most particularly, constraints of time. However, we believe strongly that the diversity of people who live with the outcomes of policy decisions should have the opportunity to discuss and shape these limitations and thereby the privilege of appreciating the necessarily provisional nature of "science-based" decisions.
Below, we outline several steps toward implementing such a process.
Part 3 – Proposal
Recommended Steps for Implementing the Precautionary Principle
Based on the above points, we suggest that successful implementation of the precautionary principle will require agreement on the following procedural requirements. This section has been adapted from Barrett and Raffensperger (to be published in the International Journal of Biotechnology in 2002).
Step 1. Set Goals
As a decision-making framework, risk analysis/management tends to focus on questions of tolerance: How much harm are we willing to accept? How safe is 'safe enough'?
In contrast, the precautionary principle invites us to ask much broader, "upstream" questions. For example, in the case of GM food, we might begin by asking how we can achieve ecologically, economically and socially sustainable agriculture, rather than starting with the question of "acceptable risks" of GM products. Addressing upstream questions will require setting long-term, innovative policy goals, and devising the most appropriate and effective means of meeting those goals. This process of "backcasting" has been used successfully in countries such as Sweden and the Netherlands to set far-reaching targets for environmental protection.
Step 2. Assess Alternatives
Setting goals and broadening the scope of questions on the table will likely inspire creative and alternative approaches to policy and technology development. Under a precautionary approach, concerted effort should be made to investigate and assess alternatives to the proposed technology or activity through an "alternatives assessment" (see O'Brien, 2000, Making Better Environmental Decisions, MIT Press). The techniques of risk assessment and cost-benefit analysis may be useful tools in helping to identify, evaluate and compare potential benefits and risks of various alternatives.
Diversifying options and broadening perspectives are well-established methods for making decisions under uncertain circumstances, and are essential to all other aspects of the precautionary principle.
3. Adopt Transparent and Open Processes
Under the precautionary principle, open and transparent decision-making processes should be instituted before substantial commitment of public funds to a technology or policy area, particularly if these decisions impact directly on the well-being of the public. Open, participatory processes allow a broader range of knowledge, experience and values to guide decision-making -- an approach which makes sense from both from a technical and ethical point of view. Transparent processes ensure that regulatory actions can be substantiated and that decision-makers are accountable.
4. Define "Harm"
Recognition that our actions may result in harm is widely cited as reason for implementing a precautionary approach. This implies that we are dealing with hazards that have been, to some extent, identified and/or that are plausible, while bearing in mind that additional harms may be unforeseen (as discussed below). The way in which "potential harm" is defined, however, will bear significantly on conclusions regarding the safety of a particular technology.
A precautionary approach requires that the following parameters of harm are critically examined.
5. Analyse Uncertainty
- What is the nature of the potential harm?
Adverse effects may manifest at the level of:
- Socio-cultural, economic and political systems
Impacts may also be distributed across time. They may be observed immediately and have only short-term effects (e.g. over a single generation), or they may emerge over the long-term or be persistent in the environment, lasting many years and generations.
- What is the extent of potential harm?
Several interpretations of the precautionary principle specify that preventative action should be taken when the threat of harm is "serious". Often, however, we do not know how serious a particular threat might be. We need some guidelines for evaluating the severity of harms that we are attempting to prevent. Such guidelines should consider hazards that are:
- Not reversible
- Unfairly distributed
- Portentous of future threats or trends
- Restrictive of other options
- What standards are used to measure harm?
How we define harm ultimately depends on our points of reference. In assessing the impacts of GM food and crops, for example, Canadian and US policies use the concept of "substantial equivalence" to measure potential impacts of GM crops relative to current agricultural practices. Other countries have adopted different baselines for assessing harm -- organic agriculture or long-term goals of sustainable development for example -- and consequently have reached alternative conclusions about the safety and acceptability of GM products. Because standards of comparison profoundly affect the outcome of regulatory decisions, a precautionary approach requires that such reference points be negotiable, flexible and explicit. (This problem is sometimes referred to as the difficulty of defining the 'base case'.)
The above parameters address important questions about the type and extent of potential harm. However, because the precautionary principle applies under conditions of uncertainty, answers to these questions are necessarily provisional and incomplete; they alert us to the potential for known harms to occur but cannot comprehensively identify or predict specific impacts.
Under the precautionary principle, we must further probe the limits of our knowledge through uncertainty analysis. This should comprise at least the following three considerations.
6. Shift the Burden of Proof
- Types of uncertainty.
Many scientific studies and risk assessments acknowledge a specific, limited, type of technical uncertainty that derives from incomplete data, ambiguous results or variability of the experimental system. This uncertainty is usually expressed as confidence intervals or distributions around a mean, and can often be reduced through further scientific investigation. There are, however, additional types and sources of uncertainty that must be taken into account under the precautionary principle. For example:
- Methodological or model uncertainty refers to the unreliability of chosen methods to accurately represent the system under study.
- Political uncertainty arises from decisions not to examine a particular hazard, not to develop adequate alternatives, or through deliberate efforts to conceal of downplay the extent of hazards or uncertainty.
- Epistemological uncertainty arises from the confluence of biological, ecological, socio-cultural and political systems, and hence from the inevitable gap between the closed conditions of experimental research, and the open-ended and contingent circumstances in which the results of scientific research are applied (see Wynne 1992, Global Environmental Change, 2:117-127). This type of uncertainty signals the limits of our predictive capabilities and therefore "borders on ignorance".
- Standards of evidence and error bias.
Under the precautionary principle, strict standards of evidence (e.g. beyond reasonable doubt) and emphasis on avoiding false positives are often neither reasonable nor appropriate. This is because it is relatively easy to demonstrate "no effect" in highly complex and variable conditions, especially when investigating low frequency or low probability events. Detecting an adverse effect requires carefully planned and monitored experiments. Negative conclusions (no effect) may simply indicate that tests are not robust enough to detect an effect.
The precautionary principle advocates, therefore, that we adopt a weight-of-evidence standard, and shift error biases to avoid false negatives. In a weight-of-evidence approach, information from numerous, diverse sources is weighed in a deliberative style of decision-making. Because a weight-of-evidence standard does not rely solely on quantitative measures of cause-and-effect before concluding that an activity may have adverse impacts, this process helps to shift error biases toward the side of caution. When quantitative studies are used, a precautionary approach requires that the probabilities of false negatives, as well as false positives are made explicit, i.e. through statistical power calculations. Such precautionary measures are now standard requirements for many ecological studies, particularly those related to resource management and conservation.
- Admissible evidence.
The weight-of-evidence standard described above admits multiple lines of evidence in reaching conclusions on a particular issue. This process acknowledges the difficulty of conducting quantitative, controlled, repeatable and generalisable experiments that are also accurate predictors of highly complex and variable systems. A plurality of information sources, together with an open, deliberative process, creates a more robust foundation for decision-making under these circumstances. Lines of evidence that should be considered in policies on GM crops, for example, include:
- Multiple disciplines and cross-disciplinary investigation
- Multiple sources of expertise, including local and traditional knowledge
- Multiple sources of information and ways of reasoning, including case studies, computer models, and correlation to other technologies
- A diversity of expressed values and goals.
We suggest that implementing the precautionary principle will require reframing the narrow legal conception of "burden of proof" into a broader "burden of responsibility" that is more appropriate and applicable in an administrative context. The burden of responsibility should entail:
7. Take Precautionary Action
- Testing: responsibility for funding and/or performing tests on the potential impacts of the proposed technology or activity, and demonstrating that there are no less harmful alternatives;
- Open consultation and third party review: proponents should allow for independent review of testing procedures, data and conclusions and public disclosure of information relevant to evaluating impacts;
- Notification and informed consent: responsibility to inform consumers and importers
- Protective measures: responsibility to adopt measures to prevent negative impacts of existing (currently marketed) products
- Liability: financial responsibility for adverse impacts through mechanisms such as performance bonds.
By incorporating the above elements, the precautionary principle assumes the role of comprehensive technology assessment -- an overarching framework that may include other types of analyses such as risk analysis, environmental impact assessment and social impact assessment.
Implementing the precautionary principle, therefore, does not simply or necessarily mean banning new technologies or activities. It is not anti-scientific, or anti-technology. Rather, the principle can be (and has been) used to initiate new policy directions, new approaches to technology development and more robust scientific practices that acknowledge complexity and uncertainty. "Clean" technologies and production methods, reverse-listing procedures, right-to-know legislation, and adoption of "best available technologies" are examples of precautionary action. Regardless of the chosen course of action all applications of the principle must incorporate broad questions about goals and alternatives; support ongoing research into the potential harms, benefits and uncertainties of a particular technology; establish processes for open, transparent decision-making; ensure the burden of responsibility rests on proponents; and develop mechanisms for feedback and learning.
Part 4. Response to Questions
To respond explicitly to relevant questions posed in the Discussion Document:
- Is this discussion paper clear in describing the precautionary approach and the guiding principles?
Many sections of the Document are very clear. However, as we have discussed above, the Document remains unclear on the role of science and other factors in decision-making under the precautionary principle.
- Would the principles achieve the goal of preventing misuse or abuse (misinterpretation, misapplication) when implementing the precautionary approach?
Most likely, it would not because the relationship among scientific evidence, judgement, values, society's chosen level of concern, traditional knowledge etc. remains unclear. We suggest that the focus of this document should be to establish a process for anticipating and resolving these issues.
- Does this discussion paper adequately balance the various needs of Canadians? If not, how could it establish the right balance?
The Document rightly recognises the need for public involvement in decision-making. However, it is not clear how this will be implemented. Specifically, how will a diversity of opinions will be included and how will "public involvement" be reconciled with the stated emphasis on scientific knowledge?