The Default Value Approach to the Precautionary Principle

In science, when information is lacking, the reasonable response is to suspend judgement. When incomplete scientific information is to be used for decision-making purposes, such as regulation, the option of suspending judgement is not available. In such situations the precautionary principle may be used. One of several problems with the precautionary principle is that it is poorly defined and difficult to operationalize. We propose a way of operationalizing the precautionary principle through assigning cautious default values to variables that are needed in the risk analysis but are nevertheless unknown. A formalized model is introduced, in which the precautionary principle is interpreted in terms of default values of chemicals regulation. Four different methods for choosing default values (positive list, negative list, statistical expectation, and precaution) are discussed.     

Safety,Risk and the Precautionary Principle: Rethinking Precautionary Approaches to the Regulation of Transgenic Plants

Operationalizing the Cartagena Protocol on Biosafety will require resolving disputes about the meaning of the term 'precautionary approach' in the treaty text. Although the terms precautionary approach and precautionary principle have been referred to in the regulation of transgenic plants for nearly a decade, no customary expectation of what actions either requires has developed. If specific obligations for regulators, regulated entities, or both are not established, compliance will be impossible. This essay examines various interpretations of the precautionary principle, discusses their shortcomings, and suggests a way to rethink the regulation of transgenic plants that focuses on genuine uncertainty. Transgenic plants with familiar phenotypes should be subject to considerably less regulatory scrutiny than those whose risks are genuinely unknown, or known to pose heightened risk.     

The Precautionary Principle in Practice: Applying the Ashford Framework to Technological Risk

The precautionary principle reflects an old adage — an ounce of prevention is worth a pound of cure. Its four central components include: taking preventative action in the face of uncertainty; shifting the burden of proof to proponents of an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing public participation in decision processes. Scholars in a range of fields have identified U.S. environmental laws, regulations, and decisions exhibiting precaution de facto. This study moves beyond the traditional treatments of the subject, the morass of definitions systematizing precaution into its basic elements. It poses a further question, within the current legal system and existing laws, how might the precautionary principle be implemented by modifying aspects of a statute? By applying a conceptual legal precautionary framework to a specific example of technological risk management, Washington State's energy facility siting statute, we reveal deficiencies in four areas: compensation issues; burden of proof; Type I or II error preferences; and systematic comparisons. Supplying these would, in all likelihood, ensure a more effective statute and process as well as an outcome consistent with legislative goals. However, were an explicit statement of the precautionary principle introduced, parties dissatisfied with an outcome would seek judicial review, and extensive litigation could counter the legislative mandate of abundant energy at a reasonable cost.     

Precautionary Health Risk Assessment: Case Study of Biological Insecticides

In conventional risk assessment approaches, experts define the scientific questions that can legitimately be asked and the burden of proof is on the potentially exposed community to show that a proposal is unsafe. Here I propose an alternative approach, precautionary health risk assessment, in which the scientific questions to be addressed are defined by community consultation. I illustrate the approach with a case study of exposure to biological insecticides. This illustrates how community consultation can have a critical influence on the outcome of a health risk assessment. Government agencies may be reluctant to involve stakeholders in health risk assessments because this involves a loss of political control of the process. However, precautionary approaches are likely to lead to better health outcomes where decision stakes and scientific uncertainty are both high.     

The Precautionary Principle in the Information Society

The Precautionary Principle aims to anticipate and minimize potentially serious or irreversible risks under conditions of uncertainty. Thus it preserves the potential for future developments. It has been incorporated into many international treaties and pieces of national legislation for environmental protection and sustainable development. However the Precautionary Principle has not yet been applied systematically to novel Information and Communication Technologies (ICTs) and their potential environmental, social, and health effects. In this article we argue that precaution is necessary in this field and show how the general principle of precaution can be put in concrete terms in the context of the information society. We advocate precautionary measures directed towards pervasive applications of ICT (Pervasive Computing) because of their inestimable potential impacts on society.     

Risk Communication and the Precautionary Principle

The perception of risks for environment and health deriving from globalization processes and an uncontrolled use of modern technologies is growing everywhere. The greater the capacity of controlling living conditions, the larger is the possibility of misusing this power. In environmental and occupational health research we tend to reduce the complexity of the observed phenomena in order to facilitate conclusions. In social and political sciences complexity is an essential element of the context, which needs to be continuously considered. The Precautionary Principle is a tool for facing complexity and uncertainty in health risk management. This paper is aimed at demonstrating that this is not only a problem of technical risk assessment. Great attention should also be paid to improve risk communication. Communication between the stakeholders (experts, decision makers, political and social leaders, media, groups of interest and people involved) is possibly the best condition to be successful in health risk management. Nevertheless, this process usually runs up against severe obstacles. These are not only caused by existing conflicts of interest. Differences in values, languages, perceptions, resources to have access to information, and to express one's own point of view are other key aspects.     

The Precautionary Preference: An American Perspective on the Precautionary Principle

The precautionary principle, a familiar constituent of international and European environmental law, has only very recently entered the vocabulary of domestic environmental policy debates in the United States. The question naturally arises what role such a principle should play in American law. By breaking down statements of the precautionary principle into distinct ele ments, one can more readily find ways in which U.S. law reflects the precau tionary principle. This analysis reveals that American environmental law con tains precautionary elements and goals in many and varied settings, from the management of natural ecosystems, to pollution control standards, to risk assessment methodology. However, the precautionary approach appears in a highly diluted or compromised form. With rare exceptions, U.S. law balances precaution against other considerations, most importantly cost. Therefore, while precautionary elements are firmly entrenched in U.S. environmental law, it is more accurate to say that it reflects a precautionary preference rather than the precautionary principle.     

Trends in the Development of Ecological Risk Assessment and Management Frameworks

Ecological risk assessment and management have grown from a long history of assessment and management activities aimed at improving the everyday lives of humans. The background against which ecological risk assessment and management has developed is discussed and recent trends in the development of risk assessment and management frameworks documented. Seven frameworks from five different countries are examined. All maintain an important role for science, suggest adaptive approaches to decision-making and have well-defined analytical steps. Differences in approaches toward the separation of policy and science, the preference for management over assessment, the inclusion of stakeholders, the iterative nature of the analytical cycle, the use of decision criteria and economic information suggest considerable evolution in framework design over time. Despite the changes, no consensus on the design of a framework is apparent and work remains to be done on refining an integrative framework that effectively incorporates both policy and science considerations for environmental management purposes.     

Ecological Indicators in Risk Assessment: Workshop Summary

Ecological indicators can be defined as relatively simple measurements that relay scientific information about complex ecosystems. Such indicators are used to characterize risk in ecological risk assessment (ERA) and to mark progress toward resource management goals. In late 1997, scientists from the U.S. Environmental Protection Agency and from the Chemical Manufacturers Association (CMA) held a workshop to explore opportunities for collaborative research and scientific exchange on the development and application of ecological indicators. Several scientific challenges were identified as they relate to problem formulation, exposure and effects assessment, and risk characterization. Chief among these were a better understanding of multiple stressors (both chemical and non-chemical), characterization of reference sites and natural variability, extrapolation of measures to ecologically relevant scales, development of comprehensive, ecosystem-based models that incorporate multiple stressors and receptors, and a consistent system for evaluating ecological indicators.     

Unraveling the Chimera: A Corporate View of the Precautionary Principle

Current controversy regarding how and when the precautionary principle should be applied to the introduction of new technology has created a false dichotomy, a dichotomy between conventional, risk-based decision making and an alternative paradigm that seemingly denounces risk assessment. As we compare views of the precautionary principle relative to our own operating standards for ensuring human and environmental safety, we perceive no irreconcilable conflict. Due precaution is entirely consistent with sound, cost-effective management of the risks and uncertainties inherent in new technologies. The principle guides prudent risk management actions under a prescribed set of circumstances, i.e., potentially serious or irreversible risks, or incomplete characterization (high uncertainty). In order to enable technological innovation toward a more sustainable future, it is critical that any preventative measures taken under these circumstances be provisional in nature, pending adequate risk characterization. As with all risk management decisions, we contend that the principle requires consideration of a suite of factors beyond risk assessment, including political, social, legal and cultural considerations to tailor the measures proportionately to the risk at hand. Overall, we are encouraged to find relatively broad agreement in this interpretation with a number of key multinational governmental and trade institutions.     

Policy on Synthetic Biology: Deliberation,Probability, and the Precautionary Paradox

Synthetic biology is a cutting‐edge area of research that holds the promise of unprecedented health benefits. However, in tandem with these large prospective benefits, synthetic biology projects entail a risk of catastrophic consequences whose severity may exceed that of most ordinary human undertakings. This is due to the peculiar nature of synthetic biology as a ‘threshold technology’ which opens doors to opportunities and applications that are essentially unpredictable. Fears about these potentially unstoppable consequences have led to declarations from civil society groups calling for the use of a precautionary principle to regulate the field. Moreover, the principle is prevalent in law and international agreements. Despite widespread political recognition of a need for caution, the precautionary principle has been extensively criticized as a guide for regulatory policy. We examine a central objection to the principle: that its application entails crippling inaction and incoherence, since whatever action one takes there is always a chance that some highly improbable cataclysm will occur. In response to this difficulty, which we call the ‘precautionary paradox,’ we outline a deliberative means for arriving at threshold of probability below which potential dangers can be disregarded. In addition, we describe a Bayesian mechanism with which to assign probabilities to harmful outcomes. We argue that these steps resolve the paradox. The rehabilitated PP can thus provide a viable policy option to confront the uncharted waters of synthetic biology research.     

Ten Years of the Relative Risk Model and Regional Scale Ecological Risk Assessment

It has been 10 years since the publication of the relative risk model (RRM) for regional scale ecological risk assessment. The approach has since been used successfully for a variety of freshwater, marine, and terrestrial environments in North America, South America, and Australia. During this period the types of stressors have been expanded to include more than contaminants. Invasive species, habitat loss, stream alteration and blockage, temperature, change in land use, and climate have been incorporated into the assessments. Major developments in the RRM have included the extensive use of geographical information systems, uncertainty analysis using Monte Carlo techniques, and its application to retrospective assessments to determine causation. The future uses of the RRM include assessments for forestry and conservation management, an increasing use in invasive species evaluation, and in sustainability. Developments in risk communication, the use of Bayesian approaches, and in uncertainty analyses are on the horizon.     

Framework for the Integration of Health and Ecological Risk Assessment

The World Health Organization's International Programme on Chemical Safety (IPCS), the Organization for Economic Cooperation and Development (OECD), and the U.S. Environmental Protection Agency have developed a collaborative partnership to foster integration of assessment approaches for human health and ecological risks. This paper presents the framework developed by that group. Integration provides coherent expressions of assessment results, incorporates the interdependence of humans and the environment, uses sentinel organisms, and improves the efficiency and quality of assessments relative to independent human health and ecological risk assessments. The paper describes how integration can occur within each component of risk assessment, and communicates the benefits of integration at each point. The goal of this effort is to promote the use of this internationally accepted guidance as a basis for harmonization of risk assessment.     

Adding Value to Ecological Risk Assessment with Population Modeling

Current measures used to estimate the risks of toxic chemicals are not relevant to the goals of the environmental protection process, and thus ecological risk assessment (ERA) is not used as extensively as it should be as a basis for cost-effective management of environmental resources. Appropriate population models can provide a powerful basis for expressing ecological risks that better inform the environmental management process and thus that are more likely to be used by managers. Here we provide at least five reasons why population modeling should play an important role in bridging the gap between what we measure and what we want to protect. We then describe six actions needed for its implementation into management-relevant ERA.     

Ecological Risk Assessment and Ecological Epidemiology for Contaminated Sites

After 20 years of development, ecological risk assessment is widely accepted. However, it is evolving in response to a variety of technical and societal pressures. First, pressure for greater simplicity and standardization arise from the expectation that risk assessments should require little time and resources but be defensible. Second, the advance of the environmental sciences and increasing awareness of the complexity of ecological responses generate pressure for greater realism. Third, the dominance of human health risk assessment generates a pressure to integrate ecological risk assessment with that dominant field. Fourth, the demand for cost-benefit analysis creates pressure for integration with environmental economics. Finally, the need to connect the practice of ecological epidemiology with risk-based decision-making creates a pressure of the formation of a single integrated ecological assessment practice.     

Using Ecological Risk Assessment Principles in a Source Water Protection Assessment

It has become increasingly common to apply ecological risk assessment (ERA) principles to watershed and regional scale environmental management. This article describes the application of watershed ERA principles to the development of a source water protection assessment and a strategic watershed management plan. The primary focus was on the protection of drinking water quality, a concern typically addressed by human health risk assessors. The approach emphasizes adaptations to the problem formulation phase of ERA (defining assessment endpoints, developing conceptual models and an analysis plan) suitable for watershed management planning in a multi-objective, multi-stressor context. Physical, chemical, and biological attributes were selected for primary drinking water quality assessment endpoints, and coupled with additional assessment endpoints relevant to other environmental and social management objectives. Conceptual models helped the planning team to better understand and communicate the multiple natural and human stressors in the watershed and the causal pathways by which they affected drinking water. The article provides an example of the types of adaptations that can make ERA principles suitable for watershed management related to human health goals, and illustrates the efficiency of integrating health and ecological assessments.     

Bioindicators Versus Biomarkers in Ecological Risk Assessment

The biomarker approach, adopted from medical toxicology, is subject to several theoretical and practical difficulties when used to address environmental problems. The problems are related to the definition that emphasizes measurement but does not specify a requirement to establish cause-effect linkages. An improved definition for a bioindicator is reviewed. The sentinel species approach is judged to be a biomarker rather than a bioindicator, and therefore of limited use for environmental risk assessment. An empirical weight of evidence approach to improve the utility of sentinel species is proposed.     

Ecological Risk Assessment of China's Freshwater Ecosystems Applying the Relative Risk Model: Toward an Ecosystem-Based Water Management in China

The relative risk model (RRM) was applied to evaluate the ecological risk characterization of the freshwater ecosystems in China, from both overall and region-specific levels. Ten large-scale river basins (further broken into 15 risk regions) in China were chosen as the study objects; 10 sources, two habitats, and seven endpoints were identified as risk components. The results reveal the status of ecosystem conditions, key ecological risk issues, and the spatial heterogeneity of the freshwater ecosystems in China. The policy implications for the ecosystem-based water management contained in the results are discussed. The results obtained in this article provide a deeper understanding of the ecological risk characterization of the freshwater ecosystems in China, and aid in promoting the applications of the RRM as the tool for ecosystem-based water management.