Search

The International Union for the Conservation of Nature (IUCN) proposes the use of the Environmental Impact Classification for Alien Taxa to standardize the classification of introduced species (IS) based on their environmental impact. The IUCN invoked the precautionary principle (PP) via 2 rules: the impact assigned to a taxon must be the maximum recorded impact across different impact assessments, and when the main driver of environmental damage is unclear, it must be assumed to be caused by the IS. The validity of PP is conditioned on the degree of emergency that warrants urgent decisions and on the scientific evidence demonstrating the advantages of applying a preventive measure. The application of an impact classification system does not arise in the context of an emergency that requires management; it occurs before the decision‐making phase. Thus, PP should not be used in early steps of the risk analysis process. The IUCN also did not provide enough scientific basis to justify the use of PP. Instead, the PP rules appear to be rooted primarily in the ethical value system underlying conservation science. Conservationists assign intrinsic value to native species by virtue of their roles and relationships within ecological and evolutionary systems and processes; thus, individuals introduced in new environments not only cease to have value because they are no longer part of that natural diversity and lack those links with the rest of the ecosystem, but they become a threat to what conservationists value most. The consequence of this belief is that all introduced taxa will have an impact at some level, suggesting that values justify the PP rules. [ABSTRACT FROM AUTHOR]

Potential future application of engineered gene drives (GDs), which bias their own inheritance and can spread genetic modifications in wild target populations, has sparked both enthusiasm and concern. Engineered GDs in insects could potentially be used to address long-standing challenges in control of disease vectors, agricultural pests and invasive species, or help to rescue endangered species, and thus provide important public benefits. However, there are concerns that the deliberate environmental release of GD modified insects may pose different or new harms to animal and human health and the wider environment, and raise novel challenges for risk assessment. Risk assessors, risk managers, developers, potential applicants and other stakeholders at many levels are currently discussing whether there is a need to develop new or additional risk assessment guidance for the environmental release of GD modified organisms, including insects. Developing new or additional guidance that is useful and practical is a challenge, especially at an international level, as risk assessors, risk managers and many other stakeholders have different, often contrasting, opinions and perspectives toward the environmental release of GD modified organisms, and on the adequacy of current risk assessment frameworks for such organisms. Here, we offer recommendations to overcome some of the challenges associated with the potential future development of new or additional risk assessment guidance for GD modified insects and provide considerations on areas where further risk assessment guidance may be required. [ABSTRACT FROM AUTHOR]

This paper analyzes how nanotechnologies are regulated in terms of chemical products and processes. It aims to identify what historical and economic forces have fueled the two primary approaches to regulating chemicals. The methodology implemented here involved a historical and content analysis of what legally resulted in the two main regulatory instruments: regulatory risk analysis and precautionary principle. Historical and economic forces, on the one hand, are market forces, which are reflected in the regulatory risk analysis approach regarding risks, health, and sustainability and which tend to encourage market development and seek to individualize the technical relationships and potential effects of processes, technologies, and products. The forces of life, on the other hand, prioritize the protection of the health of people and ecosystems and are reflected in the precautionary approach. Although these two approaches do not appear to be contradictory because they have different intrinsic scopes (temporal, spatial, and social), they, as well as the concepts and methodologies that they promote, actually reflect social forces that eventually clash with each other. Both trends are here exemplified in the context of nanotechnologies. The results of the analysis show that the legal expression of those forces represents interests of various origins: those that favor the market in one case, and those that favor the defense of life and health in the other. [ABSTRACT FROM AUTHOR]

The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law of the CJEU, the conditions for the application of this principle are met. Such conditions are the existence of a risk to the environment and public health and uncertainty. Given this qualification as a precautionary measure, whether the Commission had complied with the procedural obligations that surround the implementation of this principle under EU law was assessed. Some shortcomings are identified concerning the risk assessment conducted by the European Medicines Agency and the risk management carried out by the Commission. [ABSTRACT FROM AUTHOR]

The precautionary approach to fisheries management advocates for risk‐averse management strategies that include biological reference points and account for scientific uncertainty (i.e. process, model and observation uncertainty). In this regard, two approaches have been recommended: (a) biomass reference points to safeguard against low stock biomass, and (b) uncertainty buffers that reduce the catch limit as a function of the scientific uncertainty. This study compares the effectiveness of these two precautionary approaches in recovering over‐exploited fish stocks. We evaluate the performance of more than 80 harvest control rules (HCRs) within a stochastic management strategy evaluation (MSE) framework for three stocks with contrasting life‐history parameters and under various levels of scientific uncertainty. The results show that both approaches reduce the risk of overfishing at the expense of expected yield. This risk‐yield trade‐off strongly depends on the HCRs, life‐history parameters of the species, as well as the level of the scientific uncertainty. Nevertheless, some combinations of biomass threshold and limit reference points as well as uncertainty buffers lead to a more favourable risk‐yield trade‐off than other rules. This study elucidates the multiple factors affecting the effectiveness of management strategies and highlights key features of HCRs for precautionary fisheries management. [ABSTRACT FROM AUTHOR]

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. [ABSTRACT FROM AUTHOR]

Risk assessors, risk managers, developers, potential applicants, and other stakeholders at many levels discuss the need for new or further risk assessment guidance for deliberate environmental releases of gene drive-modified organisms. However, preparing useful and practical guidance entails challenges, to which we offer recommendations based on our experience drafting guidance. [ABSTRACT FROM AUTHOR]

Sesame allergy is a public health problem in many countries around the world. The purpose of this study is to determine the occurrence of sesame allergen in unlabelled or labelled free-sesame Middle Eastern foods with or without Precautionary Allergen Labelling (PAL) 'may contain' and estimate the risk incurred by the Canadian population allergic to sesame with a focus on products purchased in Middle Eastern grocery stores and bakeries in Montreal, Canada. A total of 571 samples were analysed to determine the level of sesame protein. Of the 571 samples analysed, 19% (109/571) contained sesame (results >LOQ) with concentrations of sesame proteins varying between 0.5 and 1,875 mg kg−1 and 35% (199/571) contained traces (a value between LOD and LOQ). Unpackaged products were found to present the highest proportion of sesame containing samples (36%). For packaged products, 16% (27/173) of samples with PAL and 3% (5/173) without PAL were found to contain sesame. A probabilistic approach was used to estimate the risk incurred by the Canadian consumers allergic to sesame. Our evaluation estimated that 33 to 308 allergic reactions may occur out of 10 000 individuals ingesting one type of bakery product contaminated at a level of 0.6–74 mg kg−1 sesame proteins. The incidence and level of sesame cross-contact reported in this study demonstrate that sesame allergic consumers could react if they ignore the precautionary allergen statements on product labels. Attention to sesame as a potential cross-contact agent and as a priority allergen calls for better management, given the growing interest in this ingredient to be included in food formulations. Enhanced risk management efforts must be coupled with targeted risk communication covering both producers and consumers as to the need to adopt and an approach for the application of precautionary allergen labelling based on risk. [ABSTRACT FROM AUTHOR]

Despite aiming to make conservation science and practice more effective, many conservationists default to excessive precaution, advocating conservative actions—or even inaction. The field suffers from an understandable aversion to unintended consequences, especially for approaches involving biotechnology and "next‐generation" interventions. We call this default precautionary attitude among conservationists the ethos of restraint and argue for replacing it with an ethos of responsible conservation action. Loosening the ethos of restraint will require (a) more holistically accounting for comparative risks, benefits, and costs of novel approaches; (b) gathering more data on their consequences; (c) engaging in dialogue about intended consequences and conservation values; and (d) pursuing adaptive implementation strategies. Adopting an ethos of responsible conservation action requires grasping that precaution and proaction are not diametrically opposed attitudes. Instead, we must decide what level of precaution or proaction is warranted, and what to do, on a case‐by‐case basis. [ABSTRACT FROM AUTHOR]

The precautionary nature of risk regulation in the European Union (EU) and the United States (US) is an ongoing debate. Theoretical contentions over 'who is more precautionary' confirm that the degree of relative precaution may lead to different levels of protection, but also suggest that precaution needs to be evaluated against different parts of the regulatory process. This paper addresses a new case of transatlantic split which has occurred with the adoption of the EU regulation on alien invasive species. This regulation aims to drive important changes at the trade–environment nexus and reflects Europe's integrated policy approach to environmental, health, and safety risks. We have carried out a comparative analysis by examining parts of the regulatory process. We argue that differences in legal and policy frameworks, risk assessment, and risk management structures have left the EU and the US wide apart as to their risk governance ambitions. The EU exhibits more precautionary approach with regard to these parts, as compared to the US. Our finding suggests that policy divergence, as reflected in this case, is true for both stringency and regulatory process, expanding literature discussions on precaution in these systems. Yet, with the EU's regulation being relatively new, there are still implementation issues up for debate. [ABSTRACT FROM AUTHOR]

Background and objective: Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle. Materials and methods: From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence. Results: The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk‐based decision‐making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision‐making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus‐based decision‐making process. Conclusions: While the field of donation‐safety research is expanding rapidly, there is an urgent need to formalize the decision‐making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision‐making process and to ensure that this is performed consistently. Our framework provides an easy‐to‐implement approach for standardizing risk assessments, especially in the context of limited scientific evidence. [ABSTRACT FROM AUTHOR]

In this paper, we explore how the politics of European regulation and risk governance for innovative agricultural biotechnologies, with the continuing emphasis on the precautionary principle, has problematised conventional norms of evidence-based risk-related decision-making. Based on a study we conducted that analysed how the EU regulatory system had operated in practice in the context of two of the company Syngenta's genetically modified (GM) crops (Bt11 and GA21), and through two stakeholder workshops, we highlight the tensions in the current regulatory system in Europe, the implications for the future regulation of new and emerging advanced agricultural biotechnologies in the EU, and suggest areas where there may be a need for further regulatory adjustment. [ABSTRACT FROM AUTHOR]

In India, the restriction of genetically modified (GM) crops and derived products not approved in the country necessitates surveillance for transgene(s) in plant material/products imported into the country. CDC Triffid expressing acetolactate synthase (ALS) conferring tolerance to sulphonylurea herbicide is the only GM flax event that has got approval in Canada in 1990s and subsequently deregistered in 2001. In spite of deregistration, the unexpected and unauthorized detection of traces of GM flax in the consignments imported from Canada to Europe has further necessitated the stringent monitoring of flax shipments from Canada for suspected GM incidents. This study reports on the detection of transgenic elements being present in GM flax employing polymerase chain reaction assays, in a set of 123 flaxseed accessions imported from Canada for research purpose. Based on the tests conducted, none of the transgenic elements, namely, nos promoter (P-nos), nos terminator (T-nos), nptII marker gene, ALS transgene, as present in the GM flax CDC Triffid were detected in any of the tested accessions. The well-known herbicide tolerance gene cp4-epsps, being employed in Roundup® Ready events of other crops, was also not detected in these samples. This case study has demonstrated the importance of monitoring the presence of transgene(s) in flaxseed imports, and such studies need to be carried out for the imported seeds from the country where GM events of respective crop are being approved whereas they have not been approved in the country of import as a part of precautionary approach. [ABSTRACT FROM AUTHOR]

Traditional approaches and study design in cancer epidemiology have not been very successful in identifying and evaluating adequately the potential risk and/or protective factors associated with the disease. The main reasons for the failure are often due the small study sample size, and inadequate exposure information. In this paper, issues and approaches relevant to these two challenges are discussed. Multicentre study is proposed as a way to increase study size and to mitigate criticism about meta-analysis of independent studies. A multicentre study of large cohort or case-control studies also offer an exciting opportunity to study the contribution of epigenetic events that may be associated with lifestyle and environmental risk factors for human health. Optimizing methods for exposure assessment and how to reduce exposure to misclassification represent a difficult component in epidemiological studies. A potentially useful approach for improving exposure estimation is to rely on biomarkers of exposures. An example is provided to demonstrate how biomarkers of exposures could provide valuable information in addition to exposure measurements in traditional epidemiological studies. Finally, it is argued that risk assessment and the precautionary principle should not be viewed as conflicting paradigms but, rather, as a complementary approach for developing appropriate policies to address risks posed by exposure to carcinogens and a wide spectrum of other health hazards. [ABSTRACT FROM AUTHOR]

Concerns about the effects of bisphenol A (BPA) on human brain and behavior are not novel; however, Grohs and colleagues have contributed groundbreaking data on this topic in a recent issue of Environmental Health. For the first time, associations were reported between prenatal BPA exposure and differences in children's brain microstructure, which appeared to mediate the association between this exposure and children's behavioral symptoms. Findings in numerous previous mother-child cohorts have pointed in a similar worrying direction, linking higher BPA exposure during pregnancy to more behavioral problems throughout childhood as assessed by neuropsychological questionnaires. Notwithstanding, this body of work has not been adequately considered in risk assessment. From a toxicological perspective, results are now available from the CLARITY-BPA consortium, designed to reconcile academic and regulatory toxicology findings. In fact, the brain has consistently emerged as one of the most sensitive organs disrupted by BPA, even at doses below those considered safe by regulatory agencies such as the European Food Safety Authority (EFSA). In this Commentary, we contextualize the results of Grohs et al. within the setting of previous epidemiologic and CLARITY-BPA data and express our disquiet about the "all-or-nothing" criterion adopted to select human data in a recent EFSA report on the appraisal methodology for their upcoming BPA risk assessment. We discuss the most relevant human studies, identify emerging patterns, and highlight the need for adequate assessment and interpretation of the increasing epidemiologic literature in this field in order to support decision-making. With the aim of avoiding a myopic or biased selection of a few studies in traditional risk assessment procedures, we propose a future reevaluation of BPA focused on neurotoxicity and based on a systematic and comprehensive integration of available mechanistic, animal, and human data. Taken together, the experimental and epidemiologic evidence converge in the same direction: BPA is a probable developmental neurotoxicant at low doses. Accordingly, the precautionary principle should be followed, progressively implementing stringent preventive policies worldwide, including the banning of BPA in food contact materials and thermal receipts, with a focus on the utilization of safer substitutes. [ABSTRACT FROM AUTHOR]

Objectives Work and research with nanomaterials (NMs) has primarily focused on innovation, toxicity, governance, safety management tools, and public perceptions. The aim of this study was to identify academia and industry occupational safety and health (OSH) managers' perceptions and handling of NMs, in relation to safety culture. Methods Semistructured interviews were carried out with OSH managers at six academic institutions and six industrial companies. The interview statements were coded into five topics regarding NMs: risk comprehension, information gathering, actions, communication, and compliance. The statements were then coded according to a five-step safety culture maturity model reflecting increasing occupational safety maturity from passive, to reactive, active, proactive, and exemplary occupational safety. Results The safety culture maturity of the academic institutions were primarily active and proactive , whereas the industry group were primarily active and reactive. None of the statements were rated as exemplary , with the majority reflecting an active safety culture. The topics varied from a passive approach of having no focus on NMs and regarding risks as a part of the job, to applying proactive measures in the design, production, application, and waste management phases. Communication and introduction to OSH issues regarding NMs as well as compliance provided challenges in both academia and industry, given the increasing cultural and linguistic diversity of students/staff and employees. Workplace leaders played a crucial role in establishing a legitimate approach to working safely with NMs, however, the currently available OSH information for NMs were described as insufficient, impractical, and inaccessible. There was an embedded problem in solely relying on safety data sheets, which were often not nanospecific, as this may have led to underprotection. Conclusions There is a need for more structured, up-to-date, easily accessible, and user-friendly tools and information regarding toxicity and threshold limit values, relevant OSH promotion information, legislation, and other rules. The study underscores the need for politicians and engineers to collaborate with communication experts and both natural and social scientists in effectively framing information on NMs. Such a collaboration should allow for flexible deployment of multilevel and integrated safety culture initiatives to support sustainable nanotechnology and operational excellence. [ABSTRACT FROM AUTHOR]

The article makes the case for the precautionary principle, where the balance of nature needs to trump the immediate profit of innovation. The penetration of technology in Africa revives old stereotypes about the continent, hegemonic dynamics reminiscent of colonization, and stir a verity of social conflicts as profits and corporate interests come before the people and the environment. [ABSTRACT FROM AUTHOR]

Food allergy is a major public health concern with avoidance of the trigger food(s) being central to management by the patient. Food information legislation mandates the declaration of allergenic ingredients; however, the labelling of the unintentional presence of allergens is less defined. Precautionary allergen labelling (PAL) was introduced by the food industry to help manage and communicate the risk of reaction from the unintended presence of allergens in foods. In its current form, PAL is counterproductive for consumers with food allergies as there is no standardized approach to applying PAL. Foods with a PAL often do not contain the identified food allergen while some products without a PAL contain quantities of common food allergens that are capable of inducing an allergic reaction. Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM) was an EU‐funded project that aimed to improve the management of food allergens by the food industry for the benefit of people with food allergies. Within iFAAM, a clinically validated tiered risk assessment approach for food allergens was developed. Two cross‐stakeholder iFAAM workshops were held on 13‐14 December 2016 and 19‐20 April 2018. One of the objectives of these workshops was to develop a proposal to make PAL effective for consumers. This paper describes the outcomes from these workshops. This provides the basis for the development of more informative and transparent labelling that will ultimately improve management and well‐being in consumers with food allergy. [ABSTRACT FROM AUTHOR]

The numbers and impacts of non-native species (NNS) continue to grow. Multiple ranking protocols have been developed to identify and manage the most damaging species. However, existing protocols differ considerably in the type of impact they consider, the way evidence of impacts is included and scored, and in the way the precautionary principle is applied. These differences may lead to inconsistent impact assessments. Since these protocols are considered a main policy tool to promote mitigation efforts, such inconsistencies are undesirable, as they can affect our ability to reliably identify the most damaging NNS, and can erode public support for NNS management. Here we propose a broadly applicable framework for building a transparent NNS impact evidence base. First, we advise to separate the collection of evidence of impacts from the act of scoring the severity of these impacts. Second, we propose to map the collected evidence along a set of distinguishing criteria: where it is published, which methodological approach was used to obtain it, the relevance of the geographical area from which it originates, and the direction of the impact. This procedure produces a transparent and reproducible evidence base which can subsequently be used for different scoring protocols, and which should be made public. Finally, we argue that the precautionary principle should only be used at the risk management stage. Conditional upon the evidence presented in an impact assessment, decision-makers may use the precautionary principle for NNS management under scientific uncertainty regarding the likelihood and magnitude of NNS impacts. Our framework paves the way for an improved application of impact assessments protocols, reducing inconsistencies and ultimately enabling more effective NNS management. [ABSTRACT FROM AUTHOR]

There is a significant gap between the safety management in the Chinese colleges and many renowned colleges in other countries. The subject of this study is how to assess the performance of health, safety, and environment (HSE) in Chinese college laboratories. The assessment system is established by three parts. First of all, HSE performance assessment indicators for laboratories in Chinese colleges are identified based on the previous studies. Then set valued iteration is used to calculate the weights of the various indicators. Following that, multiple attribute group decision-making (MAGDM) method with Pythagorean 2-tuple linguistic operators is used to assess the laboratory HSE performance in colleges. Finally, taking a college in Sichuan Province as an example, the proposed method is used to assess the laboratory HSE performance. The assessment result shows that the proposed method used in this study is practical and feasible. [ABSTRACT FROM AUTHOR]

The traditional approaches and study designs in cancer epidemiology have not been very successful in identifying and evaluating adequately the potential risk and/or protective factors associated with the disease. The main reasons for the failure are often due to small study sample size, and inadequate exposure information. In this paper, issues and approaches relevant to these two challenges are discussed. Multicentre study is proposed as a way to increase study size and to mitigate criticism about meta-analysis of independent studies. Optimizing methods for exposure assessment and how to reduce exposure misclassification represent a most difficult component in epidemiology studies. A potentially useful approach for improving exposure estimate is to rely on biomarkers of exposures. An example is provided to demonstrate how biomarkers of exposures could provide valuable information in addition to exposure measurements in traditional epidemiological studies. Finally, it is argued that risk assessment and the precautionary principle should not be viewed as conflicting paradigms but, rather, as a complementary approach for developing appropriate policies to address risks posed by exposure to carcinogens and a wide spectrum of other health hazards. [ABSTRACT FROM AUTHOR]

Tolerance for blood transfusion risks is very low, as evidenced by the implementation of expensive blood tests and the rejection of gay men as blood donors. Is this low risk tolerance supported by the precautionary principle, as defenders of such policies claim? We discuss three constraints on applying (any version of) the precautionary principle and show that respecting these implies tolerating certain risks.Consistencymeans that the precautionary principle cannot prescribe precautions that it must simultaneously forbid taking, considering the harms they might cause.Avoiding counterproductivityrequires rejecting precautions that cause more harm than they prevent.Proportionalityforbids taking precautions that are more harmful than adequate alternatives. When applying these constraints, we argue, attention should not be restricted to harms that are human caused or that affect human health or the environment. Tolerating transfusion risks can be justified if available precautions have serious side effects, such as high social or economic costs. [ABSTRACT FROM AUTHOR]

Adolescents are now significant users of internet pornography. Samples of voluntary consumption were identified from 14 countries. Considered collectively they demonstrate that boys are much more interested in viewing pornography than girls and that both genders watch more pornography as they get older. By age 18 most boys are consumers. From a risk management point of view, internet pornography has not been proven to be a safe product. It poses dangers similar to any activity that has a high potential for the development of problematic behaviors or addiction through sustained overconsumption. Until causality linking pornography consumption to harm is either disproven or demonstrated to be very low, there is a strong case for governments and policy makers to intervene in the unrestricted supply of internet pornography to all consumers, particularly adolescents. The precautionary principle should be invoked to minimize the likelihood that internet pornography consumption will become a global public health crisis. Prevention of harm is always preferable to treating it. Reducing risk from internet pornography by discouraging its consumption is relatively inexpensive and easy to do. [ABSTRACT FROM AUTHOR]

An editorial is presented which discusses the study regarding the precautionary principles in massive transfusion protocols (MTPs) for trauma patients. It mentions the survey stating that trauma centers in the U.S. are maintaining thawed group A plasma to supplement AB plasma to be use as the initial resuscitation of trauma patients whose ABO status is unknown. It also expreses the public health issue within the transfusion community.

This paper proposes that generic cancer risk assessments be based on the integration of the Linear Non-Threshold (LNT) and hormetic dose–responses since optimal hormetic beneficial responses are estimated to occur at the dose associated with a 10 −4 risk level based on the use of a LNT model as applied to animal cancer studies. The adoption of the 10 −4 risk estimate provides a theoretical and practical integration of two competing risk assessment models whose predictions cannot be validated in human population studies or with standard chronic animal bioassay data. This model-integration reveals both substantial protection of the population from cancer effects (i.e. functional utility of the LNT model) while offering the possibility of significant reductions in cancer incidence should the hormetic dose–response model predictions be correct. The dose yielding the 10 −4 cancer risk therefore yields the optimized toxicologically based “regulatory sweet spot”. [ABSTRACT FROM AUTHOR]

We distinguish among three types of actions that can be taken to alleviate the consequences of natural disasters: precautionary efforts (made ex ante), relief efforts (made in the immediate aftermath of a disaster), and recovery efforts (made ex post). We argue that recognizing this distinction lessens many of the problems that the literature attributes to government intervention and hence expands the scope of government action following disasters. Relief is less likely than recovery to generate over-supply by the government and over-reliance by victims. [ABSTRACT FROM AUTHOR]

The precautionary approach of the Cartagena Protocol on Biosafety, if incorporated into legislation of countries as a precautionary principle (PP), could cause great difficulty in decision-making on genetically modified organisms. No consensus seems to be possible on the interpretation of the PP, as responsibility often is passed on to political decision-making and, eventually, to court rulings. A case study on the assessment of possible unintended effects of endogenous allergens illustrates the complexity decision-makers may experience. We review the descriptions of the PP and the debate on the interpretation and conclusions that a number of authors have come to, as a step closer to a solution in decision-making. South Africa may have to consider the PP in the broader context of its food security needs, which would require improved communication as an additional step in the process of risk analysis. [ABSTRACT FROM AUTHOR]

Many critics of bioenhancement go to considerable lengths to establish the existence of reasons against pursuing bioenhancements but do little to establish the absence of reasons in favor. This suggests that they accept what Allen Buchanan has called the conclusive reasons view (CRV). According to this view, our reasons against bioenhancement are obviously decisive, so there is no need to balance them against countervailing reasons. Buchanan criticizes the CRV by showing that the reasons most commonly adduced against bioenhancement are not decisive, or, at least, not obviously so.In this article, I suggest that both Buchanan and the authors to whom he is responding underestimate the strength of the case for the CRV. There are, I argue, harm-based reasons against bioenhancement that provide stronger support to the CRV than the reasons that have most often been adduced by critics of enhancement. However, I then argue that even these harm-based reasons are not obviously decisive. Thus, I ultimately agree with Buchanan about the falsity of the CRV, though I disagree with him about the reasons for its falsity. [ABSTRACT FROM PUBLISHER]

[Display omitted] • Microplastics have been analyzed widely in the Norwegian environment. • Multi-actor discussions in Norway identified several persistent knowledge gaps. • Validation and harmonization of analytical methods are needed to advance research. • Elucidating drivers and mechanisms of microplastic toxicity is still a challenge. • Complex ecological interactions inspire adopting a precautionary approach. • Multi-actor communication is essential to define and facilitate strategic research. Given the increasing attention on the occurrence of microplastics in the environment, and the potential environmental threats they pose, there is a need for researchers to move quickly from basic understanding to applied science that supports decision makers in finding feasible mitigation measures and solutions. At the same time, they must provide sufficient, accurate and clear information to the media, public and other relevant groups (e.g., NGOs). Key requirements include systematic and coordinated research efforts to enable evidence-based decision making and to develop efficient policy measures on all scales (national, regional and global). To achieve this, collaboration between key actors is essential and should include researchers from multiple disciplines, policymakers, authorities, civil and industry organizations, and the public. This further requires clear and informative communication processes, and open and continuous dialogues between all actors. Cross-discipline dialogues between researchers should focus on scientific quality and harmonization, defining and accurately communicating the state of knowledge, and prioritization of topics that are critical for both research and policy, with the common goal to establish and update action plans for holistic benefit. In Norway, cross-sectoral collaboration has been fundamental in supporting the national strategy to address plastic pollution. Researchers, stakeholders and the environmental authorities have come together to exchange knowledge, identify knowledge gaps, and set targeted and feasible measures to tackle one of the most challenging aspects of plastic pollution: microplastic. In this article, we present a Norwegian perspective on the state of knowledge on microplastic research efforts. Norway's involvement in international efforts to combat plastic pollution aims at serving as an example of how key actors can collaborate synergistically to share knowledge, address shortcomings, and outline ways forward to address environmental challenges. [ABSTRACT FROM AUTHOR]

This paper argues that Edward B. Lewis served as a type of independent academic radiation LNT-cancer risk assessment-stalking horse for the BEAR Genetics Panel, a task for which he had no expertise or experience (e.g. radiation, leukemia, epidemiology and statistical modelling). His efforts produced an insufficiently documented, strongly biased, and high-profile paper in Science (May 17, 1957), whose principal conclusions had not been proven, he asserted privately, in writing. This inconclusive perspective was well camouflaged in the published paper by means of sophisticated wordsmithing. At the time his academic department head George Beadle came to chair the BEAR Genetics Panel in the summer of 1956, the Beadle-inspired-Lewis LNT activity acquired an urgency when a study of 70,000 offspring from survivors of the A-bombs failed to show genetic damage after a decade of careful study, undercutting Panel recommendations. With Beadle's guidance, the Lewis effort redirected the Panel's focus from the atomic bomb genetic damage study, which had acrimoniously disrupted Panel relationships and priorities, to more immediate disciplinary/professional opportunities with concerns about fallout, leukemia risks and a new cancer causation role for mutation. The serious limitations of the Lewis paper affected neither its publication in Science nor its receiving an editorial endorsement, possibly due to influence by powerful Panel members, such as Bentley Glass, one of only six senior editors for Science. The Science publication restored, even though improperly, the scientific and moral initiatives of the Panel and led directly to multiple high level LNT recommendations for cancer risk assessment based on the Precautionary Principle, which Lewis asserted, and which remains in place today in essentially all countries. The present paper explores how such a scientific long-shot and quasi-stalking horse, who was unsupported by BEAR Panel members during the withering criticism prompted by his Science article, nevertheless endured in the pursuit of his LNT goal, becoming strikingly successful in achieving a global cancer risk assessment revolution which remains in place. • The scientific basis for cancer risk assessment is shown to be invalid. • Low dose linearity for radiation-induced mutation and leukemia are not supported. • Flawed analyses and profound ideological bias resulted in the acceptance of LNT. [ABSTRACT FROM AUTHOR]

This study proposed a framework to estimate health risks due to exposure of mixture of nanoparticles (NPs) from surface water, for the first time, as per authors' best knowledge. The framework consisted of hazard identification, exposure assessment, dose-response assessment, risk characterization and risk management steps. Concentrations of mixture of NPs and associated ions were compiled and range of values were used for exposure estimation. The resulting concentrations of nanoparticle and metal ions in simulated digestive fluid were calculated and used to estimate exposure dose to digestive system organs during a hypothetical exposure of water during recreational activity. Exposure doses of different possible combinations of ZnO NP, CuO NP, Zn2+ and Cu2+ ions were considered. The ECHA weight-of- evidence framework was used for formulating hypotheses and collecting evidence for determining reference dose (RfD) and interaction parameter for estimating hazard interaction value (an index for risk) as per the USEPA modified weight-of-evidence method for estimating risks of binary NPs and ions. RfD values of CuO (0.0262 mg/kg/d) and ZnO NP (0.0315 mg/kg/d) were derived using information from rat-based oral toxicity studies and assumed values of uncertainty factors. The results showed that mixture of NPs under environmentally-relevant conditions do not pose any health risk. The uncertainty analysis indicated that ZnO + CuO + Zn + Cu ion suspension posed the highest risk. The switchover analysis indicated that NP concentration >0.207 mg/L resulted in risk estimate greater than 1 and pose risk. Although risk estimate was found to be smaller than 1 under the studied natural water condition, efforts should be made to continue monitoring mixture of NPs as a precautionary approach. More efforts are required to obtain data on (i)toxicity of mixture of NPs, (ii)their interaction effects, (iii)fractions of NPs reaching target organ in order to accurately predict risk. Potential benefit of this framework is in its usage for development of structure for estimating exposure risks due to mixture of NPs and ions from surface water. This can also be used to adopt methodology for gathering information on evidence required in different steps of risk assessment process, like obtaining RfD/uncertainty factor -related parameters in dose-response assessment step, deriving interaction and mixture toxicity-related parameters in risk estimation step. • Risk assessment framework for mixture of nanoparticles (NPs) in water using the USEPA modified Weight-of-evidence method. • Use of ECHA weight-of-evidence method for hypothesis development, problem formulation, data collection, weightage assignment. • Estimation of realistic dose of NPs and ions using information on dissolution of NP in simulated digestive fluid. • Significant effect of the interaction parameter of the WoE method on risk estimate. • No significant health risk due to exposures of ZnO NP or CuO NPs in surface water below 0.207 mg/L concentration. [ABSTRACT FROM AUTHOR]

Ecosystem restoration is gaining political and economic support worldwide, but its exact targets and costs often remain unclear. A key issue, both for predicting restoration success and assessing the costs, is the uncertainty of post-restoration development of the ecosystem. A specific combination of uncertainties emerges when ecosystem restoration would negatively affect pre-restoration species conservation values. Such dilemma appears to be common, but largely ignored in restoration planning; for example, in historically degraded forests, wetlands and grasslands that provide novel habitats for some threatened species. We present a framework of linked options for resolving the dilemma, and exemplify its application in extensive mire restoration in Estonia. The broad options include: redistributing the risks by timing; relocating restoration sites; modifying restoration techniques; and managing for future habitats of the species involved. In Estonia, we assessed these options based on spatially explicit mapping of expected future states of the ecosystem, their uncertainty, and the distribution of species at risk. Such planning documentation, combined with follow-up monitoring and experimentation, can be used for adaptive management, by funding organizations and for academic research. • Ecosystem restoration may conflict with species values of novel or remnant origin. • Conflict severity depends on significance, perspective, and uncertainty of values. • Solutions include mitigation, timing, gradual or partial restoration and offsets. • In Estonian mire restoration the conflict was resolved using spatial planning. [ABSTRACT FROM AUTHOR]

The ediotor focuses on study conducted by the researcher T.S. Rector on threats of precautionary principle including risk management and unintended consequences. Topics discussed include requirement to watch out unintended consequences of treatment as well as initiatives to avoid the same, determination of patient with dose-dependent QT interval prolongation by the U.S. Food & Drug Administration and absence of adequate information and adherence to the precautionary principle may lead to harms.