Clear-cut cases of decision-making under risk (known probabilities) are unusual in real life. The gambler’s decisions at the roulette table are as close as we can get to this type of decision-making. In contrast, decision-making under uncertainty (unknown probabilities) can be exemplified by a decision whether to enter a jungle that may contain unknown dangers. Life is usually more like an expedition into an unknown jungle than a visit to the casino. Nevertheless, it is common in decision-supporting disciplines to proceed (...) as if reasonably reliable probability estimates were available for all possible outcomes, i.e. as if the prevailing epistemic conditions were analogous to those of gambling at the roulette table. This mistake can be called the tuxedo fallacy . It is argued that traditional engineering practices such as safety factors and multiple safety barriers avoid this fallacy and that they therefore manage uncertainty better than probabilistic risk analysis (PRA). PRA is a useful tool, but it must be supplemented with other methods in order not to limit the analysis to dangers that can be assigned meaningful probability estimates. (shrink)

At workplaces where nanomaterials are produced or used, risk assessment and risk management are extremely difficult tasks since there is still limited evidence about the risks of nanomaterials. Measurement methods for nanoparticles are contested and safety standards have not yet been developed properly. To support compliance with the legal obligation of the employer to care for safe workplaces a large number of ‘soft’ regulatory tools have been proposed (e.g. codes of conduct, benchmarks, standards). However, it is not clear whether and (...) under which conditions soft regulation is complied with. This article discusses the potential advantages and drawbacks of soft regulation. It explores compliance issues when exposure measurement devices and other technology-related factors are involved. The exploration of three examples of soft regulation on occupational health and safety (a ministerial recommendation on preliminary exposure benchmarks, a nano-specific guidance of a chemical company and a public–private OHS guideline) shows that the capacity of the regulated parties to comply depends on the availability of appropriate technological devices and methods, technical expertise and other resources. When technological prerequisites are met, compliance is likely to increase. (shrink)

Scientists are divided on the status of hypothesis H that low doses of ionizing radiation (under 20 rads) cause hormetic (or non-harmful) effects. Military and industrial scientist s tend to accept H, while medical and environmental scientists tend to reject it. Proponents of the strong programme claim this debate shows that uncertain science can be clari ed only by greater attention to the social values in uencing it. While they are in part correct, this paper argues that methodological analyses (not (...) merely attention to social values) also can help clarify uncertain science. The paper analyzes ve measurement uncertainties , as well as seven methodological value judgments, relevant to H. Using criteria of internal and external consistency, as well as predictive power, it argues that metascience also helps resolve this debate. And if so, then value-laden, policy-relevan t science may need, not only more attention to social values in order to resolve and to clarify disputes, but also more conceptual and methodological analyses of science. (This paper suggests what such methodological analyses might be like and uses the case of low-dose risks from radiation to illustrate its points, while a companion paper (“Chemical Hormesis, Conceptual Clari cation, and the Warrant for Policy-Driven Science”) in this same issue of POS suggests what such conceptual analyses might be like and uses the case of low-dose risks from chemicals to illustrate its points.) If this paper’s thesis holds in the very politicize d “hard case” of radiation hormesis, then it suggests that the metascientist s may be right about what is also often necessary to clarify scienti c disputes. (shrink)

We argue that a responsible analysis of today's evidence-based risk assessments and risk debates in biology demands a critical or metascientific scrutiny of the uncertainties, assumptions, and threats of error along the manifold steps in risk analysis. Without an accompanying methodological critique, neither sensitivity to social and ethical values, nor conceptual clarification alone, suffices. In this view, restricting the invitation for philosophical involvement to those wearing a "bioethicist" label precludes the vitally important role philosophers of science may be able to (...) play as bioevidentialists. The goal of this paper is to give a brief and partial sketch of how a metascientific scrutiny of risk evidence might work. (shrink)

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms, challenges current practices of governance and science. When a governing body is confronted by a technology whose use has potential environmental risks, some form of risk analysis is typically conducted to help decision makers consider the range of possible benefits and harms posed by the technology. Environmental risk assessment is a critical component in the governance of nanotechnology and genetically engineered organisms because the uncertainties and complexities surrounding these technologies (...) pose such risk potential. However, GEOs are unique technologies, and there is widespread, international recognition that many traditional forms of ERA are not well-suited for evaluating them. Nanotechnology products are also likely to need different models of risk assessment, as there is very little information on their fate, transport, and impacts in the environment. (shrink)

Risk assessment is an evidence-based analytical framework used to evaluate research findings related to environmental and public health decision-making. Different routines have been adopted for assessing the potential risks posed by substances and products to human health. In general, the traditional paradigm is a hazard-driven approach, based on a monocausal toxicological perspective. Questions have been raised about the applicability of the general chemical risk assessment approach in the specific case of nanomaterials. Most scientists and stakeholders assume that the current standard (...) methods are in principle suitable, but point out that experimental aspects and practical guidelines need specific adaptations. Beyond this laboratory level, risk assessment of nanomaterials also faces a number of substantive and procedural limitations, which are intrinsically attributed to the general orthodoxy of the risk assessment concept. Moreover, the developed formalism used to organize scientific knowledge is closely interlinked with the underlying governance design and the mode of interaction between the two spheres of ‘science’ and ‘decisions’. This contribution will provide a closer look at the evolution of different institutional settings for risk assessment in the context of decision-making. Improved risk governance frameworks with different narratives, process designs and procedural elements will be compared. The question of a general principle of enhanced organization of risk assessment will be discussed taking account of the barriers of substantive and procedural limitations in the special case of nanomaterials. (shrink)

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms , challenges current practices of governance and science. Employing environmental risk assessment for governance and oversight assumes we have a reasonable ability to understand consequences and predict adverse effects. However, traditional ERA has come under considerable criticism for its many shortcomings and current governance institutions have demonstrated limitations in transparency, public input, and capacity. Problem Formulation and Options Assessment is a methodology founded on three key concepts in risk assessment (...) and three in governance . Developed through a series of international workshops, the PFOA process emphasizes engagement with stakeholders in iterative stages, from identification of the problem through comparison of multiple technology solutions that could be used in the future with their relative benefits, harms, and risk. It provides “upstream public engagement” in a deliberation informed by science that identifies values for improved decision making. (shrink)

Transgenic plants are now being used to develop pharmaceutical and industrial products in addition to their use in crop improvement. Using confinement requirements, these transgenic plants are grown and processed under conditions that prevent intermixing with commodity crops. Regulatory agencies in the United States have provided guidance of zero tolerance of these new industrial crops with commodity crops. While this is a worthy goal, it is theoretically unattainable. In spite of the best containment practices, there is a potential risk using (...) any system of production due to unforeseen incidences including natural disasters or exposure to workers. The precautionary principle has been used for numerous regulated articles in addressing the potential risks of new products and technology based on a risk assessment in similar situations. We present here a risk assessment model that could be used as a start to develop an accepted model for the industry. The model is based on current risk models used for other regulated articles, but adapted for these types of products. This could be used to determine action levels in the event of an unintended exposure or to ensure that detection or confinement methods are adequate to avoid risks. As an example, aprotinin, a therapeutic protein now being produced in maize, was evaluated for potential risk to humans using this model. (shrink)