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Risico’s en redelijkheid - Verkenning naar een rijksbreed beoordelingskader voor de toelaatbaarheid van risico’s (2010)
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... Door gebruik te maken van een subjectief risicobegrip wordt de veiligheidservaringoftewel subjectieve veiligheideen beleidsdoel an sich (Helsloot, Pieterman, & Hanekamp, 2010). Dit is volgens een aantal auteurs (o.a. ...
... Dit is volgens een aantal auteurs (o.a. Borgers, & Van Sliegdregt, 2009;Helsloot, Pieterman, & Hanekamp, 2010;Crains, & Wright, 2011) een onwenselijke verbreding van de zorgtaak van de overheid, onder andere omdat er geen duidelijke relatie bestaat tussen subjectieve-en objectieve veiligheid (Wagenaar, 1992 ...
... Als het niet mogelijk was een kosten-batenanalyse van bijvoorbeeld een behandeling in de gezondheidszorg te doen, zou de gehele sector een totaal willekeurige fundering hebben (De Beer, & Jackson, 2006;DeTora, 2017). Het afwegen van de kosten van risicoreducerende maatregelen tegenover de veiligheidsbaten ervan is een voorwaarde voor proportioneel risicobeleid (Helsloot, Pieterman, & Hanekamp, 2010;Helsloot, 2012;Van Wee 2013;Plasterk, 2015), ook op het gebied van vitale infrastructuur. De realiteit blijft dat de middelen voor levensreddende interventies beperkt zijn. ...
Bij de huidige risicobeoordelingsmethode voor vitale infrastructuur (de NLNRB) kunnen methodologische kanttekeningen worden geplaatst. Deze komen voornamelijk voort uit de kwalitatieve benaderingswijze en het subjectieve risicobegrip. In dit artikel worden vijf ontwerpprincipes opgesteld waaraan een methodologisch verantwoorde risicobeoordelingsmethode zou moeten voldoen. Vervolgens wordt er een voorstel gedaan voor een concrete, alternatieve risicobeoordelingsmethode die aan deze voorwaarden voldoet. Deze kwantitatieve methode maakt gebruik van een geobjectiveerd risicobegrip, een Bayesiaanse benaderingswijze, een vaste risiconormering van een 10 −6 overlijdenskans per jaar voor verwaarloosbaar risico, maatschappelijke kosten-batenanalyses en democratische besluitvorming voor de totstandkoming van een ethische verdeling van risico's. In een casus wordt de werking van de voorgestelde methode geïllustreerd.
... In the Netherlands, current legislative settings for biotechnology can be described as a precautionary culture, meaning that the Dutch government is held (end)responsible for inducing risks towards society, even unknown risks (Helsloot et al., 2010), assuming that research facilities or industry have complied with regulation. These regulations, which were developed in the mid-1990s, base their classification (GMO/non-GMO) and the type of risk assessment needed on the process, rather than on the end product (as is done in the United States). ...
... Therefore, risk management involves questions of values, e.g., what is safe 'enough?' and is based on a tradeoff of what would be considered acceptably safe and what not e.g., assigning an appropriate BSL. In the Netherlands, current legislative settings for biotechnology can be described as a precautionary culture where the Dutch government is held accountable for inducing risks towards society or the environment, even unknown risks (Helsloot et al., 2010), thereby assuming that research facilities or industry have complied with regulation. In addition, as risk managers are also involved in assessing and anticipating uncertain risks, they can also be ascribed a form of forward-looking responsibility which refers to making sure the 'right' precautionary measures are taken to anticipate any uncertain risks. ...
The current regulatory regime regarding GMOs within the Netherlands and Europe does ensure safety but struggles in balancing this notion with innovation. In particular, the way the Precautionary Principle (PP) is operationalized in GMO legislation has resulted in a highly precautionary culture in which there is little room to conduct research with associated uncertain risks or uncertainties – it has resulted in a culture of compliance. Although the debate on how ‘new’ genetic engineering techniques such as CRISPR should be assessed in comparison to recently exempted techniques is ongoing within the European Union (EU), this might not have any consequences for GMO regulation at all. These issues do not only stifle innovation but also illustrate that the current regime is not resilient in dealing with emerging techniques. To break free from the impasse between safety and innovation, researchers should be able to learn what uncertain risks entail, for instance, through Safe-by-Design (SbD).
The main question addressed in this thesis is: “How to create an environment that is suitable to learn safely and responsibly what uncertain risks associated with emerging biotechnologies entail?”. I conclude that to enable responsible learning by means of SbD, 3 conditions are needed; regulatory flexibility, co-responsibility and awareness. Thereby, SbD could be a suitable approach to arrive at responsible learning, given that the 3 conditions are met. If not, SbD provides guidelines to lower or mitigate known risks but fails to provide a step-by-step approach to gradually learn what uncertain risks entail. This will leave a knowledge gap between known and uncertain risks which stifles innovation and hinders risk management in ensuring future safety for people, animals and the environment.
... Therefore, risk management involves questions of values, e.g., what is safe 'enough?' and is based on a tradeoff of what would be considered acceptably safe and what not e.g., assigning an appropriate BSL. In the Netherlands, current legislative settings for biotechnology can be described as a precautionary culture where the Dutch government is held accountable for inducing risks towards society or the environment, even unknown risks (Helsloot et al., 2010), thereby assuming that research facilities or industry have complied with regulation. In addition, as risk managers are also involved in assessing and anticipating uncertain risks, they can also be ascribed a form of forward-looking responsibility which refers to making sure the 'right' precautionary measures are taken to anticipate any uncertain risks. ...
Genetic engineering techniques (e.g., CRISPR-Cas) have led to an increase in biotechnological developments, possibly leading to uncertain risks. The European Union aims to anticipate these by embedding the Precautionary Principle in its regulation for risk management. This principle revolves around taking preventive action in the face of uncertainty and provides guidelines to take precautionary measures when dealing with important values such as health or environmental safety. However, when dealing with ‘new’ technologies, it can be hard for risk managers to estimate the societal or environmental consequences of a biotechnology that might arise once introduced or embedded in society due to that these sometimes do not comply with the established norms within risk assessment. When there is insufficient knowledge, stakeholders active in early developmental stages (e.g., researchers) could provide necessary knowledge by conducting research specifically devoted to what these unknown risks could entail. In theory, the Safe-by-Design (SbD) approach could enable such a controlled learning environment to gradually identify what these uncertain risks are, to which we refer as responsible learning. In this paper, we argue that three conditions need to be present to enable such an environment: (1) regulatory flexibility, (2) co-responsibility between researchers and regulators, and (3) openness towards all stakeholders. If one of these conditions would not be present, the SbD approach cannot be implemented to its fullest potential, thereby limiting an environment for responsible learning and possibly leaving current policy behind to anticipate uncertain risks.
... In the Netherlands, current legislative settings for biotechnology can be described as a precautionary culture, meaning that the Dutch government is held (end)responsible for inducing risks toward society, even unknown risks (Helsloot, Pieterman, & Hanekamp, 2010), assuming that research facilities or industry have complied with regulation. These regulations, which were developed in the mid 1990s, base their classification (GMO/non-GMO) and the type of risk assessment needed on the process, rather than on the end product (as is done in the United States). ...
Advanced gene editing techniques such as Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR)/Cas have increased the pace of developments in the field of industrial biotechnology. Such techniques imply new possibilities when working with living organisms, possibly leading to uncertain risks. In the Netherlands, current policy fails to address these uncertain risks because risk classification is determined process‐wise (i.e., genetically modified organism [GMO] and non‐GMO), there is a strong focus on quantifiable risks, and the linearity within current governance (science–policy–society) hinders iterative communication between stakeholders, leaving limited room to anticipate uncertainties at an early stage of development. A suggested concept to overcome these shortcomings is the Safe‐by‐Design (SbD) approach, which, theoretically, allows stakeholders to iteratively incorporate safety measures throughout a technology's development process, creating a dynamic environment for the anticipation of uncertain risks. Although this concept originates from chemical engineering and is already widely applied in nanotechnology, for the field of biotechnology, there is no agreed upon definition yet. To explore the possibilities of SbD for future governance of biotechnology, we should gain insight in how various stakeholders perceive notions of risk, safety, and inherent safety, and what this implies for the applicability of SbD for risk governance concerning industrial biotechnology. Our empirical research reveals three main themes: (1) diverging expectations with regard to safety and risks, and to establish an acceptable level of risk; (2) different applications of SbD and inherent safety, namely, product‐ and process‐wise; and (3) unclarity in allocating responsibilities to stakeholders in the development process of a biotechnology and within society.
... Hiervoor kan het concept Value of Statistical Life (VSL) worden gebruikt. VSL vertegenwoordigt een bedrag waarbij de lasten van de investering in het waarborgen van een statistisch levensjaar door bijvoorbeeld veiligheidsmaatregelen in balans is met de baten die dit levensjaar oplevert (Helsloot, Pieterman & Hanekamp, 2010 ...
In the event of a nuclear accident, the government must take measures to minimise exposure of the public to radiation. People in the immediate vicinity of the site of the accident can, for example, take shelter, take iodine pills or leave the area. The measures deemed appropriate will depend on the nature and severity of the nuclear accident in question. In addition to the required effect: lower exposure to radiation, measures can also have unintended, and often negative, effects. This has become apparent after various nuclear accidents, including the one in Fukushima, in 2011.
RIVM was commissioned by the Dutch Authority for Nuclear Safety and Radiation Protection (ANVS) to list what is known about weighing up the advantages and disadvantages of crisis measures so that this can be carried out soundly, should it be necessary. A great deal of knowledge is now available but research into the individual consequences of measures is fragmentary. There is, for example, still no method for weighing up all the effects against one another or to indicate which of them is the most significant. The consequences of evacuation have been investigated more than those of other measures because it is the most far‑reaching. RIVM has looked at the consequences of measures for the public health, the economy and society in general.
... In de huidige samenleving is een extreme behoefte om risico's uit te sluiten (Helsloot, Pieterman & Hanekamp 2010). Met name daar waar het gaat om terrorisme is de angst voor geweld groot. ...
Fysieke veiligheid is een kerntaak van de overheid. Het is daarom niet verrassend of onredelijk dat de overheid wordt aangesproken op de omgang met gevaarlijke stoffen, de voedselveiligheid, de bescherming tegen overstromingen en infectieziekten of de gevaren van nieuwe technologieën.
Physical safety is a core task of government. It is neither surprising nor unreasonable for government to be held accountable for hazardous substances, for food safety, for flood protection, for the spread of infectious diseases, or for the risks involved in new technologies. In 2011 the Dutch Ministry of the Interior and Kingdom Relations asked the Scientific Council for Government Policy (WRR) to investigate the scope for the development of a generic risk policy in relation to physical safety. Do citizens and businesses take sufficient responsibility for physical safety? Could the government assume a smaller role, and what part could the business community play in this? In this report the WRR argues that in order to answer these questions a distinction needs to be made between incidents, damage, risk and uncertainty. In addition, the WRR recommends that the thinking about responsibility for safety should not be placed in the perspective of a failing government, but that the central focus should be on the ambition of good governance. Finally, the WRR suggests that thinking about safety from the perspective of damage offers a useful framework for thinking through and reassessing the distribution of responsibilities.
In my inaugural lecture, I discuss three forms of ‘debated damages’ from an economic perspective. First, pain and suffering damages for personal injuries are regarded as too low in the Netherlands, but a framework to assess the ‘correct magnitude’ is lacking. I argue that the concept of Quality Adjusted Life Years (QALYs) can offer such a framework. Applying QALYs, I conclude that Dutch damages indeed are too low. Second, a recent draft bill proposes affection damages for relatives of a victim who is seriously injured or killed. I welcome this, but I argue on the basis of economic insights that the envisaged amounts are too low. Third, mass litigation in the Netherlands is not allowed to have the object of seeking monetary compensation. A recent draft bill proposes to strike this prohibition. I welcome this, because mass damages litigation has several potential benefits. Whether the draft bill sketches an economically optimal procedure, however, is questionable
De nationale rechtsstaat blijft vooralsnog een centrale plaats innemen, als ankerpunt van een internationale rechtsorde. Wel bestaat het gevaar dat Nederland als klein land bij de internationale rechtsontwikkeling buiten spel komt te staan. Een goed functionerende rechtsstaat vraagt om voortdurende aandacht en onderhoud. Dat adviseert de WRR in zijn rapport De toekomst van de nationale rechtsstaat (rapport nr. 63, 2002).
It is ethically mandated that potential beneficial aspects of low exposure to potentially hazardous material are incorporated in the risk-benefit balancing procedure. The potential harm done by pollutants does not justify the invocation of a categorical principle. Minimisation of risk is not required if health benefits are also at stake. Society needs to find an informed consent on the threshold of risk below compensation of goods is legitimate and morally justified. Such a threshold can be defined context-specific but any human action associated with potential health impacts makes such an acceptability judgment - implicitly or explicitly. Incorporating hormesis into risk management forces regulators to make such thresholds explicit. Once as risk is below this threshold all positive and negative impacts are subject to a relative balancing towards reaching a final judgment on acceptability and necessary risk management options. This balancing risk cannot be reduced to body counts: equity issues, context specific circumstances (voluntary or involuntary exposure, for example), avoidance of risks, the nature of vulnerable groups and many other factors need to be taken into account. Such a complex weighing exercise is best performed by an analytic-deliberative process by which the best available knowledge of impacts (including their uncertain ties) is fed into a deliberating body of individuals representing all sides of the debate. Organizing and structuring an analytic-deliberative discourse for assigning painful trade-offs goes beyond the good intention to have all relevant stakeholders involved in decision making.. Discursive processes need a structure that assures the integration of technical expertise, regulatory requirements, and public values. These different inputs should be combined in such a fashion that they contribute to the deliberation process the type of expertise and knowledge that can claim legitimacy within a rational decision making procedure.
The world has many pressing problems. Thanks to the efforts of governments, NGOs, and individual activists there is no shortage of ideas for resolving them. However, even if all governments were willing to spend more money on solving the problems, we cannot do it all at once. We have to prioritize; and in order to do this we need a better sense of the costs and benefits of each “solution”. This book offers a rigorous overview of twenty-three of the world's biggest problems relating to the environment, governance, economics, and health and population. Leading economists provide a short survey of the state-of-the-art analysis and sketch out policy solutions for which they provide cost-benefit ratios. A unique feature is the provision of freely downloadable software which allows readers to make their own cost-benefit calculations for spending money to make the world a better place. © Copenhagen Consensus Center 2007 and Cambridge University Press, 2009.
The aim of the Joint Report of the two French Academies is to discuss the validity of the linear non threshold dose-effect relationship (LNT) for assessing the detrimental effects of small doses such as those delivered by X-ray examinations (0.1 mGy to 20 mGy). The conclusion of the report is that extrapolation with LNT could greatly overestimate those risks and thus may have a detrimental effect for public health by discouraging physicians and patients from performing potentially useful radiological examinations (for example a mammography or a CT scan) when the risk appears to be too large. This conclusion against the validity of LNT is based on several types of data: 1 Epidemiology has not evidenced cancer excess in humans for doses below 100 mSv. 2 Experimental animal data have not evidenced a carcinogenic effect for doses below 100 mSv. Moreover, dose-effect relationships are very seldom linear; most of them are linear-quadratic or quadratic. A practical threshold or hormetic effects have been observed in a large number of experimental studies. 3 Radiobiology: LNT assumes that the genotoxic risk (per unit dose) is constant irrespective of dose and dose rate and thus that the efficacy of the two guardians of the genome, DNA repair and elimination by death of cells with DNA damage do not vary with dose and dose rate. This assumption is not consistent with a large number of recent radiobiological data, for example mutational effect and lethal effect vary (per unit dose). The second assumption is that a given DNA damage has the same probability of initiating a cancer irrespective of the number of other DNA damage in the same cell and in the neighbouring cells. This assumption is also non consistent with recent data and modern concepts of carcinogenesis in which the microenvironment and tissue disorganisation play an important role. The existence of a threshold dose in individuals or animals contaminated by radium or thorium shows that the irradiation of a cell surrounded by non-irradiated cells does not initiate carcinogenesis. It is the responsibility of the proponents of LNT to demonstrate the validity of these two assumptions in order to justify the use of LNT. The recent reports do not provide such demonstrations.