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.     

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.     

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.     

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.     

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.     

Is There a Role for Risk Assessment within Precautionary Legislation?

Posing the question of whether the precautionary principle has a role in risk assessment effectively constrains any debate of the issue within a framework predicated on the assumption that application of risk assessment is inevitable in the formulation of regulatory decisions. The question can equally validly be expressed in terms of whether there is a role for risk assessment in the formulation of precautionary legislation. This allows the debate then to turn on consideration of two questions: Firstly, does the precautionary principle have a role in policy development? and secondly, is this role consistent and compatible with a risk based approach to regulation? When recast in these terms, a more holistic comparison of the aims and objectives of both approaches and of their relative power in the formulation of regulation becomes possible. This leads to the conclusion that the precautionary principle is, when defined and applied correctly, scientifically more robust than risk assessment. Precautionary approaches utilize scientific information and conform robustly to a scientific process but also explicitly incorporate indeterminacies into the decision making framework. Moreover, the precautionary principle when applied to environmental regulation, is more likely to lead to regulation consistent with global sustainability. On this premise, this paper argues that risk based approaches are essentially incompatible with approaches based on the precautionary paradigm, and that of the two, risk assessment is more likely to lead to unsustainable underprotection of the environment.     

The Precautionary Principle and Chemical Regulation in the U.S.

Although the statutory goals for chemical regulation are consistent with the precau tionary principle, the current U.S. regulatory program governing synthetic chemicals generally adopts little precautionary controls for the manufacture of most chemicals. For the vast majority of chemicals in use, current law places the burden of producing scientific evidence on the regulatory agency, which actually may serve to discourage companies from testing the safety of their chemicals, since the results could then be used against them in regulatory proceedings. By contrast, for a small subset of chemicals — new chemicals that belong to suspect categories — regulatory controls are quite precautionary. The result of this schizophrenic approach to chemical regulation is a regulatory system that is characterized by the absence of preventative regulation for most existing chemicals, an inequitable barrier to entry for newer safer chemicals, and a lack of information upon which to understand the safety of most chemicals in the U.S. Informal reforms of the current regulatory program are already underway to provide a more consistent and precautionary approach to chemical regulation, although to fully advance the dual goals of regulatory consistency and precaution in the regulation of chemicals, legislative action is necessary.     

Global Climate Change and the Precautionary Principle

The precautionary principle is promoted as a common sense approach that avoids unreasonable delays in taking action. A weak form of the precautionary principle, that action should not wait until all uncertainties are resolved, is indeed common sense and consistent with even the most elementary application of the methods of decision making under uncertainty to the climate change problem. The standard tools of decision analysis imply conclusions consistent with a weak precau tionary principle of taking some action before all the evidence is in. Decision theory also reveals what the basis is for stronger recommendations from the precautionary principle, to the effect that action should be based on the most pessimistic possible interpretation of the future. This conclusion is only possible if prior beliefs are so pessimistic and so strong that they would outweigh any possible new scientific evidence.     

Global Climate Change: Benefit-Cost Analysis vs. the Precautionary Principle

The precautionary principle appears to be directly applicable to the prospect that human activities will cause substantial changes to global climate. The magnitude and characteristics of the change in climate and its effects on human activities and unmanaged ecosystems are highly uncertain, potentially catastrophic, and nearly irreversible on human time scales. Nevertheless, the precautionary principle adds little to benefit cost analysis for evaluating climate policies. Benefit cost analysis can incorporate aversion to uncertainty about future outcomes, and also provides a method for balancing this concern against concern for uncertain near term policy costs. The policies favored by setting constraints on future outcomes, such as atmospheric stabilization and tolerable windows, may be less precautionary than the policies favored by benefit cost analysis, as benefit cost analysis can more readily accommodate concerns for moderate as well as severe harms. Concerns about possible climate catastrophes can also be incorporated in benefit cost analysis and, in any event, may have limited implications for policy choice.     

Precaution,threshold risk and public deliberation

It has been argued that the precautionary principle is incoherent and thus useless as a guide for regulatory policy. In a recent paper in Bioethics, Wareham and Nardini propose a response to the ‘precautionary paradox’ according to which the precautionary principle's usefulness for decision making in policy and regulation contexts can be justified by appeal to a probability threshold discriminating between negligible and non‐negligible risks. It would be of great significance to debates about risk and precaution if there were a sound method for determining a minimum probability threshold of negligible risk. This is what Wareham and Nardini aim to do. The novelty of their approach is that they suggest that such a threshold should be determined by a method of public deliberation. In this article I discuss the merits of Wareham and Nardini’s public deliberation method for determining thresholds. I raise an epistemic worry about the public deliberation method they suggest, and argue that their proposal is inadequate due to a hidden assumption that the acceptability of a risk can be completely analysed in terms of its probability.     

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.     

Germline gene editing and the precautionary principle

The precautionary principle aims to influence decision-making in contexts where some activity poses uncertain but potentially grave threats. This perfectly describes the controversy surrounding germline gene editing. This article considers whether the precautionary principle should influence how we weigh the risks and benefits of human germline interventions, focusing especially on the possible threats to the health of future generations. We distinguish between several existing forms of the precautionary principle, assess their plausibility and consider their implications for the ethics of germline modification. We also offer a novel form of the precautionary principle: the sufficientarian precautionary principle. Some plausible versions of the precautionary principle recommend placing somewhat greater weight on avoiding threats to future generations than on achieving short-term benefits. However, no plausible versions of the precautionary principle entail that we should outright reject the use germline gene editing in human reproduction and some, such as the sufficientarian version, might endorse its use.     

Technocratic precautionary principle: Korean risk governance of genetically modified organisms

Regulations for genetically modified organisms (GMOs) in Korea fluctuate between technocracy and the precautionary principle (PP). Technocratic PP denotes the coexistence, or coproduction, of technocracy with PP – a complex ensemble of technocratic, precautionary policies, and hybrids of the two. This paper analyzes four types of PP-based policies linked to Korean GMO regulations: foresight and monitoring of risk; reverse burden of proof; public participation; and the public's right to know. Korean GMO regulations are consistent with the Cartagena Protocol on Biosafety, a type of PP, but lack long-term risk assessment as well as public participation. Technocracy is embedded both in advance informed agreements as a reverse burden of proof and in proof-based GMO labeling as a right-to-know policy. Technocratic PP results in inconsistencies between PP and technocratic epistemology and the gap between PP-based institutions and technocratic practices. Technocratic PP is therefore a typical phenomenon that occurs in the “glocalization” of risk regulation.     

70年代以来柑桔灾害性天气综述及防御措施

20世纪 70年代以来 ,我国柑桔 (Ｃｉｔｒｓｒｅｔｉｃｕｌａｔａ)生产有了迅速增长 ,但由于全球气候的变化 ,出现不利于柑桔生长的灾害性天气 ,并有愈演愈烈的趋势 ,给柑桔生产带来了极大的影响。弄清灾害性天气的发生及规律 ,并提出其防御措施 ,对于进一步科学指导柑桔生产 ,完善柑桔与生境的理论 ,都有一定的现实意义。1　灾害性天气1.1　周期性大冻害据统计 ,公元 14 5 0 - 1979年的 5 2 9年中共出现了 79个严重冻害年 ,平均 10年中有 1.5次。从顺昌县及福建省的气象资料看出 ,约 9～ 10年有 1次周期性的大冻害 ,并在福建省几个县市均有…     

The Precautionary Principle: A European Perspective

The ‘precautionary principle’, as formulated in the 1992 Rio Declaration on Environ ment and Development, calls for regulatory action in the face of serious environmental risks even in the absence of full scientific certainty. This paper traces negotiation of the principle at the Rio Conference, and its history in Europe from 1969 Swedish legislation to the latest directives of the European Union. As illustrated by recent court cases from Germany and France, in particular (on nuclear power plants, electro magnetic fields, and genetically modified organisms), judicial interpretation of the principle has tended to be restrictive. Future law making in this field is likely to focus on public access to environmental risk information, and on the development of new ‘right to know’ instru ments such as mandatory product labelling and transnational pollutant release inven tories, an area where Europe can still learn from North American experience.     

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.     

The Precautionary Principle and Marine Environmental Protection: Slippery Shores,Rough Seas,and Rising Normative Tides

Law and policy implications of the precautionary principle in the field of marine environmental protection are explored in this paper in a three-part analysis. First, seven slippery aspects of the precautionary principle are highlighted, including confusion in terminology, definitional variations, definitional generalities, the spectrum of precautionary measures available, ongoing philosophical tensions and competing socioeconomic interests, debate over who should be responsible for making precautionary decisions, and limited interpretation by international tribunals. Second, the rather feeble precautionary responses to the tempestuous issues of climate change, hazardous chemicals, and overfishing are described. Third, the potential for the precautionary principle to synergize with human rights norms, such as the emerging right to a healthy environment, and other principles of sustainable development is discussed.     

Introducing the 21st Century's New Four Horsemen of the Coronapocalypse

As the world struggles through the COVID-19 pandemic, we should also be asking what systems-level measures will be needed to prevent this or even worse disasters from happening in the future. We argue that the pandemic is merely one of potentially myriad and pleiomorphic future global disasters generated by the same underlying dynamical system. We explain that there are four broad but easily identifiable systemic, pathologically networked conditions that are hurtling civilization toward potential self-destruction. As long as these conditions are not resolved, we should consider catastrophe as an inevitable emergent endpoint from the dynamics. All four conditions can be reversed with collective action to begin creating an enduring and thriving post- COVID-19 world. This will require maximal application of the precautionary principle.     

Ecological Risk Assessment and the Precautionary Principle

The Precautionary Principle, generated during the late 1980s as a unifying principle for regulating discharge of hazardous material into the North Sea, has been broadened to include a shifting of the burden of proof to the proponent of a proposed activity, adoption of a more holistic assessment process, and encompassing all environmental management decisions, not just pollution prevention activities. We argue that the Precautionary Principle remains a management philosophy, not a substitute for risk assessment. Risk assessment is a tool for organizing information used in environmental management decisions. However, increasing attention to reducing the Type II error of risk assessment studies would significantly reduce the skepticism with which many view the risk assessment process. A critical review of default assumptions used in risk assessments, inclusion of indirect effects within an ecologically relevant spatial/temporal framework, and better communication between risk assessors and risk managers also would enhance the acceptability of the process. Risk assessment can provide a sound basis for management decisions regardless of the underlying philosophies of environmental conservation or utilitarianism, but only if the inherent biases in the risk assessment assumptions are acknowledged explicitly throughout the assessment and management processes.