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Coming to grips with scientific ignorance in the governance of endocrine disrupting chemicals and nanoparticles

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... And without risk, it is not possible for science to establish the kind of causation needed for regulatory purposes (Vogel, 2004). As the hazard concept is not fully applicable to EDCs, a shift toward acceptance of concern as a substitute (risk = concern × exposure) will enable the calculation of risk (Honkela et al., 2014). The notion of concern-based risk assessment could function as a pragmatic industry policy for working with materials with persistent uncertainties and likely risks. ...
... The notion of concern-based risk assessment could function as a pragmatic industry policy for working with materials with persistent uncertainties and likely risks. This will also operationalize precautionary processes, where cost considerations tend to overrule issues of precaution when quantitative estimates of data or exposure are not available (Honkela et al., 2014). ...
Chapter
EDCs are now known to be ubiquitous in the environment, especially in aquatic ecosystems. There is a need for a policy for assessing the risk and regulations for potential EDCs in the environment. Unique characteristics of EDCs such as critical timing of exposure, nonmonotonic low dose effects, mixture effects, and delayed effects need be incorporated in the risk assessment process. Policy options discussed includes scientific uncertainty and precautionary principle, burden of proving safe products, broadened risk assessment including epigenotoxicity and bioassays for developmental endpoints. Differing viewpoints of Conventional toxicology and endocrinology in the context of regulation of EDCs and the regulatory and policy differences in the European Union and United States are highlighted.
... There are five basic stages in analyzing and addressing risk [16,[35][36][37], as demonstrated in Fig. 1. Risk is generally defined as the product of hazard and exposure [38], taking into account uncertainty. Many contemporary RAs are based on the handful of early keystone frameworks such as the report "Risk assessment in the Federal Government: Managing the process," also called the "Red Book" by the United States National Research Council (US NRC) [36,39], and the NRC's more recent "Science and Decisions: Advancing Risk Assessment" referred to as the "Silver Book" [37]. ...
... A detailed, systematic, standardized risk assessment paradigm for EDCs has not been established due to the associated scientific ambiguities, testing complexities and administrative hurdles [38,[57][58][59]. To fully understand the reasons for the slow progress, it is important to consider the ways in which EDCs do not obey traditional principles of toxicology [56,60,61]. ...
... The use of EDCs is widespread and can be found in numerous consumer goods, such as cosmetic and pharmaceutical products. However, despite a deeply felt concern and massive efforts by the scientific community and nongovernmental organizations to evaluate the effects of EDCs (see e.g., Kortenkamp et al. 2011), regulatory communities worldwide have been slow to incorporate the chemicals posing endocrine concerns into existing legislations (Vogel 2004, Hecker and Hollert 2011, Honkela et al. 2014. Although some argue that the slow detection of EDCs stems from the novel nature of the chemicals (e.g., Scheffer et al. 2003), others argue that because EDCs embody a wide range of temporalities, such as vast time frames as well as nonlinear dose and effect relationships, governing EDCs within the current risk assessment paradigm focusing on quantitative data and methods is highly challenging (Adam 1998, Held 2001. ...
... Despite differences in the U.S. and EU institutions, most importantly the demand for screening versus establishment of universally applicable criteria to enable an authorization process, the basic second-order institutional rule that governs the formation of regulatory rules is the same in both Ecology and Society 19(4): 30 http://www.ecologyandsociety.org/vol19/iss4/art30/ contexts (see Honkela et al. 2014). As one of the Finnish interviewees formulated the question in the EU: ...
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The concept of temporal fit between biophysical systems and institutions has lately received great attention by scholars interested in environmental governance. Although we agree that the concept of temporal fit is a valuable approach for highlighting the temporal challenges of governance systems, we argue that the concept is currently lacking precision with regard to temporal complexity. We build on Barbara Adam’s work on “timescapes” to offer a more nuanced account of temporal fit and misfit. We illustrate the analytical usefulness of our approach by examining the regulation of endocrine-disrupting chemicals (EDCs) within European Union’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH), a case with amplified temporal challenges. We suggest that, when addressing temporal fit, two points require greater attention. First, similar to time, temporal misfits are complex. In REACH the temporal misfit is linked to four temporal features, time frame, sequence, tempo, and timing, contributing to the insufficiency of EDC regulation. Second, the temporal features are interlinked and feed back into each other, which strengthens the temporal misfit further. In conclusion, we propose that environmental impact assessment could be used as a tool to circumvent the regulatory paralysis of EDC regulation in Europe.
... Entre los textos con alto valor de relevancia, la gestión del riesgo, el análisis de riesgo y la gobernanza fueron los más recurrentes: CEC (2000) La gobernanza, a la cual consideramos una categoría más amplia, podría centrarse en el medio ambiente o en la innovación tecnológica, o incluir la gestión de riesgos, así como los aspectos de regulación de riesgos o la política pública, por lo cual se etiquetaron como gobernanza aquellos que usaban este término y que hacían referencia a una amplia participación de distintos actores: Throne-Hols (2008) Cabe mencionar haber etiquetado por separado evaluación de riesgos y análisis de riesgos al considerar que la primera constituye un eslabón del segundo, y en muchas ocasiones las discusiones se dan por separado. Los textos con la etiqueta evaluación de riesgos suelen enfocarse en criterios o enfoques utilizados para poder evaluarlos, es decir, son de tipo técnico, por ejemplo, el de la empresa aseguradora Swiss Re (2004) y también tratan la gestión de los riesgos: Montage (2004), Hansen et al. (2008, Wickson et al. (2010), Honkela et al. (2014), Hristozov (2016, Kuraj (2017). Otros autores tratan también el tema de las metodologías para evaluar los riesgos de los productos de la NT, dentro de ellos se ubican tres textos: Sweet (2006), SCENIHR-EC (2006), Canu et al. (2018). ...
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En el presente texto se expone qué es el principio de precaución, así como la discusión en torno a porqué usarlo en el caso de la regulación y gestión de los productos de la nanotecnología. Así mismo, se exponen los resultados de la revisión de textos, principalmente académicos y oficiales, que discurren sobre el tema del principio de precaución en torno a la nanotecnología. Tras un análisis cuantitativo y cualitativo de 84 textos, se presentan los temas principales de discusión, años de publicación, relevancia de los textos para la discusión, así como las conclusiones respecto a la congruencia o no de usar el principio de precaución respecto nanotecnología.
... By framing we refer to how the participants "tame" the problems (Edzén, 2014) by moving from the realm of the unknown unknowns to making sense of the situation (Fig. 2). Even in the face of complete surprise and absence of knowledge, the human mind applies a variety of heuristic devices such as analogies and past experiences with which to impose ordered patterns on the situation (Hukkinen and Huutoniemi, 2014;Honkela et al., 2014). To understand the emergence of situational awareness and its relationship to decision-making, researchers in the POR need to document both the operational reasoning and practices, and the development of situational awareness among the participants. ...
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The magnitude and speed of change in complex human-environmental systems pose a systemic dilemma for societies. Human-induced environmental changes have pushed Earth's socio-ecological systems into an era of chronic, complex, and rapid disruptions, which call for quick intuitive decisions and effective implementation. Yet the complexity, interconnectedness and long lead times of the problems would require thoughtful and time-consuming weighing of evidence by a broad range of experts. To address the dilemma, we develop a framework, the Policy Operations Room (POR), for simultaneous practice and analysis of decision-making that prevents decisions made under time pressure from leading to unwanted socio-ecological disruptions decades ahead. The POR framework is based on earlier research on control rooms of critical infrastructures and simulation exercises of emergency response, and preliminary data from our first experiments with PORs. It immerses the policymakers in a simulated "time machine" that combines the real-time reliability management of control rooms with the long-term planning for crisis avoidance and preparedness. The POR framework can contribute significantly to novel styles of decision-making by policymakers, engineers, and corporate strategists responsible for developing urgent, forward-looking, and evidence-based policies to cope with the coming challenges of human-environmental interaction.
... Experts must navigate opportunities to advance conservation as well as risks attached to extending legitimacy to knowledge claims characterized by substantial ambiguity. The concept of emergent knowledge has potentially significant implications for practices of knowledge brokerage and professional ethics (see, e.g., Honkela et al., 2013;Pielke, 2007). ...
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The past 15 years in Finland have witnessed a diversification among environmental experts. In addition to engineers and biologists, increasing numbers of environmental scientists – from both the natural and social sciences – have entered the job market. Universities in Finland have tried to respond to this challenge by implementing innovative forms of environmental education. This article inquires into the experiences of Finnish environmental social scientists who have received a form of education that explicitly aims at increasing their capacity to discern social and ecological nuances in environmental issues. These ideas seem to promote a particular form of “practical wisdom” or phronesis. The article analyses a set of interviews with both supporters of, and participating students in, two educational programmes with “phronetic” aims to assess how these new environmental experts define their expertise and professional identities. We claim that students had to learn to frame and contextualise not only complex environmental issues, but also their own abilities and capacities as analysts of such complex issues. The research results are useful for strategic decision-making in both environmental and science policy.
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At the interface between politics and science-informed regulatory action there is hardly a more controversial combination in Europe today than the recently adopted chemicals policy overhaul entitled Registration, Evaluation, and Authorization of CHemicals (REACH) and the precautionary principle (PP). The European Commission states that REACH is underpinned by the PP. However, it is not evident how this is crystallized throughout the registration, evaluation and authorization process of REACH. Additionally, it is unclear how REACH will proactively support development of safer alternatives, a key component of precaution. The present paper examines to what extent the PP has actually been integrated in REACH. Several elements of the PP are included in REACH such as changing the burden of proof and assessment of alternatives. However, a number of important elements apparently are missing. This paper outlines some of the limitations in REACH for applying precaution and discusses possible improvements of the REACH framework to make it more supportive of precautionary decision-making.
Article
The work of Gregory Bateson, particularly his principles for a new kind of science which, in 1958 “had as yet no satisfactory name”, is revisited as a foundation for post-normal science and adaptive approaches to management of complex environmental problems. The addition of usefulness and relevance of results to decision-making as quality criteria in post-normal science implies inquiry into context at different levels of complexity (what Bateson refers to as deutero-learning). This in turn implies emphasis on processes that facilitate inclusion of diverse perspectives—which facilitates an understanding of relationships among different aspects of a problem; also, social learning, an adaptive approach to valuation that also inquires into the process by which values are constructed, and a reflexive approach to decision-making. Though marginalized from policy discourse, Bateson's principles provided the basis for the eventual development of a new shared understanding.
Article
Precautionary regulation of persistent, toxic substances is controversial because of continued and irresolvable uncertainties in ecotoxicology. This is especially an issue for people who eat wild food, still a common practice in the Arctic. Persistent organic pollutants (POPs) have been shown to interfere with hormone function and genetic regulation. In animal studies, myriad dysfunctions can be induced (manifested later in life) by low-dose POPs exposure during development. The ubiquity of POPs in biological tissue makes all organisms subject to developmental exposure. The Arctic, where subsistence living is common, is a sink region for POPs. To curtail bioaccumulation and biomagnification, the United Nations has created the Stockholm Convention in May 2001, which targets 12 chemicals for virtual elimination. Using the precautionary approach, the treaty also enables the listing of new targets as threats are recognized. The “dirty dozen” are well-documented developmental toxics and other POPs are expected to exhibit similar patterns of accumulation and harm. Arctic peoples insist that waiting for irrefutable evidence is poor planning. Nevertheless, the United States, a major signatory, has proved reluctant to ratify the language that would enable this expedient listing of new targets. Such reluctance allows health threats in the Arctic and around the world to grow. This paper reviews the theoretical background for and current evidence regarding the global issues of endocrine disruption and POPs contamination, especially as they relate to wildlife and people in the far north. It is concluded that there is an urgent need for the US to ratify the full text of the Stockholm Convention, including the provision for the listing of new targets.
Article
Approaches to visual skilling from anthropology and STS have tended to highlight the forces of discipline and control in understanding how shared visual accounts of the world are created in the face of potential differences brought about by multi-sensorial perception. Drawing upon a range of observational and interview material from an immersion in naturalist training and biological recording activities between 2003 and 2009, I focus upon jizz, a distinct form of gestalt perception much coveted by naturalist communities in the UK. Jizz is described as a tacit and embodied way of seeing that instantaneously reveals the identity of a species, relying upon but simultaneously suspending the arduous and meticulous study of an organism's diagnostic characteristics. I explore the potential and limitations of jizz to allow for both visual precision and an enchanted and varied form of encounter with nature. In so doing, I explore how the specific characteristics of wild, intangible and irreverent virtuoso performance work closely together with disciplining taxonomic standards. As such, discipline and irreverence work together, are mutually enabling, and allow for an accommodation rather than a segregation of potential difference brought about by perceptual variety.
Article
It is suggested that the recognition of new business opportunities often involves pattern recognition--the cognitive process through which individuals identify meaningful patterns in complex arrays of events or trends. Basic research on pattern recognition indicates that cognitive frameworks acquired through experience (e.g., prototypes) play a central role in this process. Such frameworks provide individuals with a basis for noticing connections between seemingly independent events or trends (e.g., advances in technology, shifts in markets, changes in government policies, etc.), and for detecting meaningful patterns in these connections. We propose that ideas for new products or services often emerge from the perception of such patterns. New business opportunities are identified when entrepreneurs, using relevant cognitive frameworks, "connect the dots" between seemingly unrelated events or trends and then detect patterns in these connections suggestive of new products or services. To obtain evidence on these proposals, we compared the "business opportunity" prototypes of novice (first-time) and repeat (experienced) entrepreneurs--their cognitive representations of the essential nature of opportunities. As predicted, the prototypes of experienced entrepreneurs were more clearly defined, richer in content, and more concerned with factors and conditions related to actually starting and running a new venture (e.g., generation of positive cash flow) than the prototypes of novice entrepreneurs. These findings offer support for the view that pattern recognition is a key component of opportunity recognition.
Article
The preparation of a new type of finite carbon structure consisting of needlelike tubes is reported. Produced using an arc-discharge evaporation method similar to that used for fullerene sythesis, the needles grow at the negative end of the electrode used for the arc discharge. Electron microscopy reveals that each needle comprises coaxial tubes of graphitic sheets ranging in number from two up to about 50. On each tube the carbon-atom hexagons are arranged in a helical fashion about the needle axis. The helical pitch varies from needle to needle and from tube to tube within a single needle. It appears that this helical structure may aid the growth process. The formation of these needles, ranging from a few to a few tens of nanometers in diameter, suggests that engineering of carbon structures should be possible on scales considerably greater than those relevant to the fullerenes.
Article
In this paper we explore the temporalities entailed in scientists' accounts of their research into the use of human embryonic stem cells (hESC) to develop beta cells for the treatment of diabetes. Stem cell scientists, by virtue of working in what is still a controversial field, find themselves engaged with a variety of more or less transparent futures, or more or less cogent expectations, about the trajectories of their research. In this paper, we initially examine a number of dimensions to these futures. At the formal level, we consider—in contrast to much of the sociological literature on futures and expectations, which has primarily focused upon the performativity of futures that are concrete, transparent, or well-articulated—futures whose import lies in their very opacity, vagueness, or immanence. We do this with the aid of Hans-Jörg Rheinberger's notions of "epistemic things" and "technical objects," primarily because this dichotomy reflects the divergent temporalities of, respectively, immanent and concrete futures. However, we also take issue with Rheinberger's exclusive orientation toward the epistemic. In a technoscientific field that is as controversial as human embryonic stem cells, scientists are overtly concerned not only with the ways in which knowledge about human embryonic stem cells is produced, but also, on the one hand, with how their work is to be regulated or rendered ethical, and, on the other, with the institutional context that enables them to enter into cross-disciplinary collaborations in order to see their work translated "from the laboratory to the bedside." In other words, we examine how, at the substantive level, futures address a range of concerns—ethical and political (or institutional) as well as epistemic—that draw in a variety of constituencies, including other-disciplinary colleagues, regulators, funders, and publics. Moreover, while Rheinberger's dichotomy of objects and things serves to structure our discussion of the way scientists talk about stem cell research, we also expand on these concepts in order to address a more extended time frame (at least beyond the temporalities entailed in the experimental process on which Rheinberger concentrates). In sum, we aim at once to advance some of the theoretical concerns of the sociology of expectations by exploring the discursive utility of the "vagueness" and "immanence" of futures, and, in keeping with much contemporary sociology of science (notably actor-network theory) we aim to widen, or heterogenize, the range of substantive futures with which scientists are engaged. Now, to demonstrate how the epistemic cohabits with the ethical and the institutional/political is, of course, hardly novel nowadays. Our particular contribution to this "amodern project" is to show how each of these entails contrasting future temporalities, and how all of these temporalities have important roles to play in scientists' epistemic, ethical, and institutional positionings. Moreover, again in keeping with the "amodern," we are suspicious of the ease with which the epistemic, the ethical, and the institutional analytically shake out. That is to say, we are interested in exploring—and we emphasize the exploratory nature of this exercise—ways in which the epistemic, ethical, and institutional might be reenvisioned. On this score, we draw on recent reworkings of Aristotle's notion of phronesis in order to suggest that hESCs might be better conceptualized as "phronesic things," as a first step toward rethinking and reconfiguring the epistemic-ethical-political futures of human embryonic stem cells. Rheinberger's dichotomy of "epistemic things" and "technical objects" provides a useful starting point for expanding upon the temporal character of stem cell scientists' accounts of the trajectories of their research. As noted, and elaborated below, Rheinberger's sensitivity to the immanent casts a different light onto the role of expectations in the research process. According to Rheinberger, "at the basis of biological research, [there is] the choice of system, and a range of maneuvers that it allows us to perform" (p. 25). In this context, "the experimental scientist deals with systems of experiments that usually are not well defined and do not provide clear answers" (p. 27); Instead, "Experimental systems are vehicles for materializing questions. They inextricably cogenerate the phenomena or material entities and the concepts they come to embody" (p. 28). Now, within...
Article
In this powerful work of conceptual and analytical originality, the author argues for the primacy of the material arrangements of the laboratory in the dynamics of modern molecular biology. In a post-Kuhnian move away from the hegemony of theory, he develops a new epistemology of experimentation in which research is treated as a process for producing epistemic things. A central concern of the book is the basic question of how novelty is generated in the empirical sciences. In addressing this question, the author brings French poststructuralist thinking—notably Jacques Derrida’s concepts of “différance” and “historiality”—to bear on the construction of epistemic things. Historiographical perspective shifts from the actors’ minds to their objects of manipulation. These epistemological and historical issues are illuminated in a detailed case study of a particular laboratory, that of the oncologist and biochemist Paul C. Zamecnik and his colleagues, located in a specific setting—the Collis P. Huntington Memorial Hospital of Harvard University at the Massachusetts General Hospital of Boston. The author traces how, between 1945 and 1965, this group developed an experimental system for synthesizing proteins in the test tube that put Zamecnik’s research team at the forefront of those who led biochemistry into the era of molecular biology.
Article
A new technology will only be successful if those promoting it can show that it is safe, but history is littered with examples of promising technologies that never fulfilled their true potential and/or caused untold damage because early warnings about safety problems were ignored. The nanotechnology community stands to benefit by learning lessons from this history.
Article
Two decades of social and political analysis have helped to enrich the concept of risk that underlies the bulk of modern environmental regulation. Risk is no longer seen merely as the probability of harm arising from more or less determinable physical, biological or social causes. Instead, it seems more appropriate to view risk as the embodiment of deeply held cultural values and beliefs ­ the songlines of the paper's title ­ concerning such issues as agency, causation, and uncertainty. These values are incorporated into the formal methodologies, such as quantitative risk assessment, by which industrial societies assess risk. The meaning of risk accordingly varies from one cultural context to another, posing difficult problems for global environmental governance. The paper reflects on the role of science in promoting convergent perceptions of risk across disparate political cultures.
The Making of Green Knowledge: Environmental Politics and Cultural Transformation Levels of learning in environmental expertise: from generalism to personally indexed specialisation
  • A Jamison
Jamison, A., 2001. The Making of Green Knowledge: Environmental Politics and Cultural Transformation. Cambridge University Press, Cambridge. Janasik, N., Salmi, O., Castá n Broto, V., 2010. Levels of learning in environmental expertise: from generalism to personally indexed specialisation. Journal of Integrative Environmental Sciences 7 (4) 297–313.
Hormonal Chaos: The Scientific and Social Origins of the Environmental Endocrine Hypothesis A review of carbon nanotube toxicity and assessment of potential occupational and environmental health risks
  • S Krimsky
  • John Hopkings
  • Baltimore
  • London
  • C.-W Lam
Krimsky, S., 2000. Hormonal Chaos: The Scientific and Social Origins of the Environmental Endocrine Hypothesis. John Hopkings, Baltimore/London. Lam, C.-W., et al., 2006. A review of carbon nanotube toxicity and assessment of potential occupational and environmental health risks. Critical Reviews in Toxicology 36, 189–217.
Confessions of a ''media hog
  • A Maynard
Maynard, A., 2009a. Confessions of a ''media hog''. Science, http://2020science.org/.