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EFSA, the European Food Safety Authority, was established in 2002 as the EU's independent risk assessment body for food and feed safety. This paper takes stock of what has been achieved and what challenges lie ahead. To do so, it first reviews scientific assessments conducted by EFSA from the perspective of a scientific experiment. This includes a hypothesis that is examined by scientific experts using existing evidence and employing agreed-upon assessment methods, the results of which are made public. Next, it considers a number of characteristics legitimising this work: quality, consistency, independence and impartiality, as well as transparency and openness. Other key considerations are relevance, evolving expectations and innovations, fitness-for-purpose and efficiency, along with sustainability of the system. By and large, the scientific assessment process in place at EFSA can be understood to mimic the conduct of a scientific experiment. However, being a regulatory support mechanism, it has some distinct characteristics. Therefore, its legitimising characteristics are not necessarily identical to those used in academic research. In conclusion, since its creation 15 years ago, EFSA has very much delivered on its mission. Whatever the achievements, the EU cannot rest on its laurels though. [ABSTRACT FROM AUTHOR]

In Pesticide Action Network Europe v Commission (Case T-536/22), Pesticide Action Network Europe (PAN Europe) contested the renewal by the European Commission of the active substance cypermethrin. This substance is used or is marketed as an insecticide in large-scale commercial agricultural applications as well as in consumer products for domestic purposes (ant and cockroach killer). PAN Europe sought the annulment of the European Commission's decision of 23 June 2022 by which the latter rejected the request for internal review made by PAN Europe in accordance with Regulation (EC) No. 1367/2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters. The applicant argued, in essence, that where a risk is established with sufficient certainty by the European Food Safety Authority (EFSA), the Commission could not disregard the conclusions of the scientific assessment by relying on its powers as risk manager. In stressing the discretion enjoyed by the Commission, the General Court dismissed the action of PAN Europe. This casenote suggests that the General Court applied the precautionary principle too formally. [ABSTRACT FROM AUTHOR]

In this paper, the framework and procedures for Pest Risk Analysis (PRA) in Germany are outlined from their beginning in the late 1990s, emphasizing its critical role in protecting plant health against new pest introductions through trade and transport. It highlights the legal requirements and prohibitions established to prevent the introduction and spread of pests, detailing the systematic scientific assessment of the likelihood of pest entry and establishment, as well as the potential damage they may cause to plants and ecosystems. The evolution of PRA procedures is discussed, noting the development of "short info sheets" for rapid, very short assessments and the introduction of standardized templates for Express PRAs. Based on standards of the International Plant Protection Convention (IPPC), these enable quick evaluations of new pests. Legislative frameworks, including the German Plant Protection Act and EU regulations, in particular the Regulation (EU) 2016/2031 on protective measures against pests of plants, govern the PRA process, mandating assessments for non-listed pests and the implementation of control measures based on risk analyses. The paper also describes the procedural instructions that guide the PRA process, ensuring high-quality assessments and timely dissemination of results to relevant authorities. Overall, it serves as a comprehensive overview of the PRA process in Germany, highlighting its importance in maintaining plant health and preventing the introduction of new plant pests into the European Union. [ABSTRACT FROM AUTHOR]

The current power distribution Internet of Things (PDIoT) lacks security protection terminals and techniques. Network security has a large exposure surface that can be attacked from multiple paths. In addition, there are many network security vulnerabilities and weak security protection capabilities of power distribution Internet of Things terminals. Therefore, it is crucial to conduct a scientific assessment of the security of PDIoT. However, traditional security assessment methods are relatively subjective and ambiguous. To address the problems, we propose to use the entropy-weight method and cloud model theory to assess the security risk of the PDIoT. We first analyze the factors of security risks in PDIoT systems and establish a three-layer PDIoT security evaluation index system, including a perception layer, network layer, and application layer. The index system has three first-level indicators and sixteen second-level indicators. Then, the entropy-weight method is used to optimize the weight of each index. Additionally, the cloud model theory is employed to calculate the affiliation degree and eigenvalue of each evaluation index. Based on a comprehensive analysis of all evaluation indexes, we can achieve the security level of PDIoT. Taking the PDIoT of Meizhou Power Supply Bureau of Guangdong Power Grid as an example for empirical testing, the experimental results show that the evaluation results are consistent with the actual situation, which proves that the proposed method is effective and feasible. [ABSTRACT FROM AUTHOR]

This report evaluates the training courses delivered under the contract OC/EFSA/SCER/2017/01 ‐ Lot 1. Within the period of January 2018 to February 2022 a total of 21 training courses were provided, eight on‐site training courses in Parma at EFSA, six virtual training courses during the Covid‐19 pandemic and seven eLearning courses comprising various numbers of modules. The courses covered different aspects of chemical and biological risk assessment and related tools, namely i) harmonisation of risk assessment methodologies for human health and ecological risk assessment of combined exposure to multiple chemicals (mixture assessment), ii) risk assessment of the application of nanoscience and nanotechnologies in agro/food/feed (nanotoxicity); iii) science‐based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides (endocrine disruption); iv) principles on genotoxicity on scientific assessment (genotoxicity) and v) computational toxicology approaches and tools (in silico). All tutors were experts in their field and had previously performed training courses on these topics. The target participants of the training courses were members of EFSA's Scientific Committee/Panels and their working groups as well as employees from national and international regulatory agencies associated with risk assessment of feed and food compounds. Members of the EFSA Networks as well as EFSA scientific staff also participated in the training courses. Courses were evaluated based on the feedback of participants and continuously improved also by integrating updated or new EFSA guidance documents. [ABSTRACT FROM AUTHOR]

The Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed (the Nano Network) was established in 2010 by the EFSA Advisory Forum, in accordance with EFSA's strategy for cooperation and networking with Member States. This Nano Network exchanges information and expertise between EFSA and Member States. It enhances dialogue among members, builds mutual understanding of risk assessment principles, improves knowledge and confidence in the scientific assessment carried out in the European Union, and increases the transparency of the process among Member States and EFSA. The annual reports of the Nano Network inform the public, stakeholders and research communities about the specific activities and achievements of the Nano Network. In 2020, the yearly meeting was held concomitantly with the 17th meeting of the EFSA cross‐cutting Working Group on Nanotechnologies, and converted to virtual network meeting in line with the measures established by EFSA to reduce the risk of coronavirus infection. The purpose of this annual meeting was to ensure information and knowledge exchange with risk assessor delegates of European Member States on the ongoing activities and further research priorities. The Nano Network members were informed on the last updates of the Guidance documents produced by EFSA in the field of Nanotechnologies, which are currently under finalisation. The Network was asked to contribute to the finalisation of the Guidances as well as their further implementation and dissemination. [ABSTRACT FROM AUTHOR]

Frequently, decisions related to health protection are taken directly on the basis of scientific assessment and they are not clearly understood, as is highlighted in the Xylella example. Therefore, this article suggests that coherent processing of information in risk assessment may allow also a "third party" (who has not already expressed a specific interest in the procedure) to participate. In order to truly grasp the EU administration, an accountable way of communicating is helpful. Therefore, communication around the democratic process might be based on EU administrative principles and rules supporting a composite administrative system: it must not neglect the implications of compliance with the multilingual principle and its consequences for EU law, which would also lead to greater trust in risk assessment. [ABSTRACT FROM AUTHOR]

• High precision and high temporal resolution land cover data were employed to evaluate landscape ecological risk. • The CA-Markov model was used to simulate land use/cover patterns under a wetland conservation scenario. • The distribution of landscape ecological risk was predicted under future land use/cover patterns. • Regional development drives changes in land use and landscape ecological risk patterns. Landscape ecological risk is the term used to describe potential negative effects of the relationship between environmental processes and landscape structure as a result of both natural and human interactions. The scientific assessment of past and prediction future ecological risks to landscapes is the basis for achieving sustainable regional development. In this study, we built an ecological risk measurement system characterized by variability in landscape composition to reflect the components of landscape ecological risk. In particular, the CA-Markov model was used to simulate the spatial pattern of land use in the Sanjiang Plain, China, under a wetland protection scenario. The evolution of the spatiotemporal land use trend in the study area was then analyzed for past (2011–2021) and future (2021–2036) periods. The results identified that construction land, farmland, water, and grassland areas exhibited an increasing trend from 2011 to 2021, while forest and wetland areas decreased each year. From 2021 to 2036, the grassland areas exhibited a downward trend, while the other land use types maintained the same previous trend, and all land use types experienced a slowdown in the degree of change. The major landscape ecological risk levels in the research region changed from medium-risk and low-risk levels (2011–2021) to low-risk and lower-risk levels (2021–2036). An evident decrease in risk is observed for farmland and construction land in the mid-region of the research district and forests in the south. In contrast, high-risk and higher-risk levels regions were smaller and distributed in the Songhua River basin in the northeast of the research region, wetland nature reserves, and the Xingkai Lake area, with an overall reduction of 59%. Based on the results, we propose several risk prevention and control management strategies. This research acts as a basis for determining Sanjiang Plain's future rational distribution of land resources and provides an example for the reduction of ecological risks in similar regions. [ABSTRACT FROM AUTHOR]

The EFSA 2nd Scientific Conference 'Shaping the Future of Food Safety, Together' gathered an international audience composed of scientists, risk assessors, risk managers, as well as non-governmental organisations and industry representatives. This article summarises the final plenary session where a panel was asked to draw out overall impressions and conclusions for the EFSA to take away for its strategic planning into the future. The main conclusions of the conference are presented under five major themes. With new methodologies, technologies, big data and the increased societal demand for enhanced engagement in the risk assessment process, there is a clear need to maintain levels of expertise from traditional areas and to consider the inclusion of new areas and sources of expertise to perform scientific assessments. Academia, industry, research and regulatory science should work together to achieve this goal. As science progresses at pace, the continued development of assessment methodologies to deal with increasingly complex assessment questions is necessary, as is the need for applied research to underpin the support to policy development that EFSA provides. Greater collaboration is needed to reach agreement on best methods and practices for scientific assessment not just internationally, but also, equally importantly, across legislative areas and scientific disciplines, and in consultation with society at large. The communication of complex science, including important concepts such as uncertainty and risk perception, is not a trivial task, and must be integrated into the scientific process. As such, the relationship between risk assessment and risk management must continue to mature, remaining close, yet independent. [ABSTRACT FROM AUTHOR]

Risk as a collective experience and public issue has redefined the politics and structure of contemporary societies. But risk is also, and increasingly so, an object of calculation and scientific assessment. These two phenomena are in many ways inseparable, but have seldom been analysed jointly. By ignoring the rise of a science of risk analysis and the institutionalization of risk-analytic techniques in government, and emphasizing science's loss of scientific authority, seminal theories of risk such as Beck's Risk society even constitute them as paradoxical. Moving beyond the seeming contradiction between these two faces of contemporary societies — a risk society and a risk analysis society — the paper shows that the capacity to engage with the sociotechnical controversies that are typical of the former, is indeed a characteristic of the regulatory sciences that pertain to the latter. [ABSTRACT FROM AUTHOR]

This document provides guidance on the strategy and methodologies followed by the European Food Safety Authority (EFSA) to consult on its scientific outputs with the objective of increasing transparency, visibility and openness of the scientific risk assessment. This initiative is framed within a larger activity devoted to the continuous improvement of the EFSA Quality Management System, a key component of the on‐going consolidation of its excellence and independency. The document illustrates all the relevant aspects to be taken into account when running a consultation: the motivation and scope of a consultation; the definition of the issues at stake in a given consultation; the identification of the relevant stakeholders to be involved in a given consultation; the selection of the most appropriate means of a consultation; and a description of how the comments received are addressed and followed up. The concluding description of the different steps in EFSA's scientific assessment that may be open for consultation, provides interested stakeholders with an explanation on EFSA's procedure to ensure consistency and harmonisation of the consultation process. [ABSTRACT FROM AUTHOR]

EFSA was requested to provide a scientific assessment of additional information submitted to demonstrate whether the active substance pymetrozine can be used such that exposure to humans may be considered negligible. The context of the assessment was that requested by the European Commission following the submission of negligible exposure data. EFSA prepared a statement where the assessment of the information is presented according to the draft technical guidance on assessment of negligible exposure of an active substance in a plant protection product under realistic conditions of use. The outcome was reached on the basis of the evaluation of the representative uses of pymetrozine as an insecticide on potato and oilseed rape as proposed by the applicant to be considered for negligible exposure. [ABSTRACT FROM AUTHOR]

• An emergency response trade-off model to assist decision-makers in taking focused action was developed. • A modified Dijkstra algorithm and a minimum cost maximum flow algorithm were employed to determine the optimal evaluation routes. • Emergency response risk levels and multiple emergency response windows of opportunity were obtained. When there are toxic gas leaks, rapid emergency response planning is vital to protect public safety. In this study, an emergency response trade-off model to assist decision-makers in taking focused action for different personnel is developed. First, a modified Dijkstra algorithm and a minimum cost maximum flow algorithm are employed to determine the optimal evaluation routes, after which an as low as reasonably practical criterion is applied to evaluate the emergency response risk levels and identify the multiple emergency response windows of opportunity. Finally, a case study based on a real incident is given to illustrate the applicability of our method. It was found that an immediate evacuation of all members of the public in a target area would expose some of them to excessive risk. It was also discovered that there is a close and complex relationship between the emergency response risk and the shelter-in-place duration and the public emergency response. Another interesting finding is that the evacuation routes in the windows of opportunities differ significantly depending on the location, and the emergency response risks associated with using the same path to evacuate at different times. These interesting findings, which were based on the scientific assessment of emergency response risks, have a massive practical impact and could assist in more accurately formulating public protection strategies. [ABSTRACT FROM AUTHOR]

We have previously reported the profile of toxic effects with respect to target organs (defined as organs showing histopathological changes) observed in rodent and non-rodent toxicity studies conducted prior to first time in man (FTIM) for 77 AstraZeneca candidate drugs (CDs) across a range of therapy areas. The main objectives of the current study were twofold; to determine which target organs observed in the FTIM studies recovered after a dose free recovery period and to determine which additional target organs were observed in subsequent chronic (⩾3 month) studies required to support longer term clinical dosing. The analysis showed that ⩾86% of findings in studies supporting FTIM either fully or partially resolved at the end of the recovery period, with profiles of recovery that were similar whether the CD progressed into man or not and across different therapy areas. Compared to observations in FTIM studies, chronic studies identified toxicities in an additional 39% of target organs. Overall these data demonstrate that chronic studies in both rodents and non-rodents provide valuable information for the risk assessment for longer term dosing in humans. In addition, the high levels of recovery demonstrated in this analysis suggest that inclusion of recovery assessments on FTIM studies should be on a case-by-case basis driven by a positive indication of need. This is in line with ICH non-clinical guidance that states that reversibility of severe nonclinical toxicities of potential clinic relevance should be assessed ‘when appropriate’, but that the evaluation can be based on a study of reversibility or on a scientific assessment. [ABSTRACT FROM AUTHOR]

In this judgment, the General Court annulled two Commission decisions authorising the placing on the market of the GM potato Amflora. The Court did not base its decision on the arguments put forward by the applicant Hungary, which contested the underlying scientific assessment of the European Food Safety Authority, but found of its own motion a breach of an essential procedural requirement in the applicable comitology procedure. Whilst the Court's proactive role in scrutinising the Commission's behaviour in the authorisation procedure of GMOs is to be welcomed, the Court arguably missed an opportunity to exercise its role as a deliberative forum for normative controversies underlying the scientific risk assessment. [ABSTRACT FROM AUTHOR]

With the increasing complication, compaction, and automation of distribution network equipment, a small failure will cause an outbreak chain reaction and lead to operational risk in the power distribution system, even in the whole power system. Therefore, scientific assessment of power distribution equipment operation risk is significant to the security of power distribution system. In order to get the satisfactory assessment conclusions from the complete and incomplete information and improve the assessment level, an operational risk assessment model of distribution network equipment based on rough set and D-S evidence theory was built. In this model, the rough set theory was used to simplify and optimize the operation risk assessment indexes of distribution network equipment and the evidence D-S theory was adopted to combine the optimal indexes. At last, the equipment operational risk level was obtained fromthe basic probability distribution decision. Taking the transformer as an example, this paper compared the assessment result obtained from the method proposed in this paper with that from the ordinary Rogers ratio method and discussed the application of the proposed method. It proved that the method proposed in this paper is feasible, efficient, and provides a new way to assess the distribution network equipment operational risk. [ABSTRACT FROM AUTHOR]

This paper extends and confirms the report of Calabrese (Calabrese, E. J. (2011b). Muller’s Nobel Lecture on dose-response for ionizing radiation: Ideology or science? Arch. Toxicol. 85, 1495–1498) that Hermann J. Muller knowingly made deceptive comments in his 1946 Nobel Prize Lecture (Muller, H. J. (1946). Nobel Prize Lecture. Stockholm, Sweden. Available at http://www.nobelprize.org/. Accessed December 12) concerning the dose-response. Supporting a linearity perspective, Muller stated there is “no escape from the conclusion that there is no threshold” while knowing the results of a recent study by Ernst Caspari and Curt Stern contradicted these comments. Recently uncovered private correspondence between Muller and Stern reveals Muller’s scientific assessment of the Caspari and Stern manuscript in a letter from Muller to Stern 5 weeks (14 January 1947) after his Nobel Prize Lecture of 12 December 1946. Muller indicated that the manuscript was of acceptable scientific quality; he indicated the manuscript should be published, but the findings needed replication because it significantly challenged the linearity hypothesis. These findings complement the previous letter (12 November 1946 letter from Muller to Stern), which revealed that Muller received the Caspari and Stern manuscript, recognized it as significant, and recommended its replication 5 weeks before his Nobel Prize Lecture. Muller therefore supported this position immediately before and after his Nobel Prize Lecture. Muller’s opinions on the Caspari and Stern manuscript therefore had not changed during the time leading up to his Lecture, supporting the premise that his Lecture comments were deceptive. These findings are of historical and practical significance because Muller’s comments were a notable contributory factor, changing how risks would be assessed for carcinogens (i.e., changing from a threshold to a linear model) throughout the 20th century to the present. [ABSTRACT FROM PUBLISHER]

Abstract: Detention for reasons of public safety, an exceptional measure created by the French law of February 25, 2008, concerns individuals sentenced for certain major crimes who have a serious personality disorder and who present a very high risk of re-offending after their release. This measure involves placing the individual in a special socio-medicolegal center after the sentence has been served. The system raises several forensic issues: was it necessary, considering the already numerous repressive measures available in France? What can be considered as a serious personality disorder? How is the supposed considerable dangerousness of the individual to be evaluated? In their critique of the increasing complexity of the French system of repression, the authors propose a unique law on the safeguarding of society and social rehabilitation, which involves periodic scientific assessment of criminal dangerousness: before sentencing, during the detention, before the criminal''s release and, if necessary, in the community. The new regulations concerning the declaration of criminal irresponsibility for mental disorder provide little progress except for the possibility for certain judges to order forensic placement of criminals as well as conditions (prohibitions and obligations) concerning them after their confinement in a psychiatric establishment. Finally, the recent procedures of the February 25, 2008 law continue to refer to the practice of the legal psychiatric report, whereas this method no longer meets the requirements of the modern scientific practice of criminology and is incapable of correctly assessing serious criminal behaviour. [Copyright &y& Elsevier]

Regulatory officials world-wide are paying attention to the process for establishing the upper level of intake for nutrient substances. The rapidly expanding use of dietary supplements, fortified foods, and functional foods, coupled with increased trade in these products, has focused attention on ensuring their safety and on harmonizing standards internationally. The more traditional approaches, in which the regulators either provided no standards for upper levels of intake or developed standards based on some arbitrary multiple of the intake level known to provide an adequate amount of the nutrient, are recognized as outdated or inappropriate for the emerging issues. Preferred approaches are those that rely on the systematic scientific assessment of risk to determine the levels of intake below which no harm may occur. The scientific study of risk is playing an increased role in establishing the regulatory upper levels of "safe" nutrient intake. Risk assessment, as a component of risk analysis, offers a scientific basis for regulatory decision-making regarding the regulators' task associated with specifying safe upper levels of intake for nutrient substances. This article describes the key components of risk assessment as they are applied within the nutrition field. Although regulatory frameworks vary from country to country and all countries retain their right to determine their own level of protection, regulatory systems operate most effectively and are more likely to converge toward harmonization if they are informed by independent, organized, and scientific reviews that are conducted systematically in a transparent manner. [ABSTRACT FROM AUTHOR]

This article discusses the development of analytical tools that allow people to assess their vulnerability to a disaster despite the low probability of its occurrence. The limited utility of probability theory in the development of a social scientific assessment of natural disasters is noted. The psychological aspects of risk assessment are considered. The disconnection between the probabilistic assessment of risks by governments and businesses and the estimation of risks by individuals, who tend to treat these issues imaginatively, is noted.

Following on from the FAO/WHO Expert Consultation and Working Group outputs on probiotics and their presentation to Codex, it is hoped that these will be used as a science-based risk assessment process for managerial decision on probiotics and that the "Guidelines for the Evaluation of Probiotics in Food" will be used as a model for scientific criteria for evaluation of health claims. It is also hoped that this work will be incorporated or taken as example for the Codex draft being prepared on health and nutrition claims and as a scientific assessment of a novel food and that the probiotic guidelines will be adopted by Industry. [ABSTRACT FROM AUTHOR]

• A novel risk evaluation model for FEAOD conducted to identify the most crucial BEs. • The Cloud-AHP algorithm was creatively proposed for weight calculation. • The GCDM method could obtain more objective group decision-making results. • Delphi iteration process had overcome the limitations of individual knowledge. Due to the catastrophic impact of Fire and Explosion Accidents in Oil Depots (FEAOD), the prevention and control of such accidents is the most critical part of risk management. In this study, a Bow-tie (BT) model was built for FEAOD, while a quantitative risk assessment and consequence assessment was performed in conjunction with the risk matrix. Then, due to the uncertainty and ambiguity of the probability data of Basic Events (BEs) during the expert elicitation process, this study creatively proposed a Cloud-Analytic Hierarchy Process (Cloud-AHP) algorithm and Group Cloud Decision-Making (GCDM) algorithm based on the Fuzzy Cloud Membership Function (FCMF). Finally, combined with the probability estimation algorithm and the sensitivity analysis, a novel risk quantitative assessment algorithm for a BT model was developed based on Cloud Model (CM) theory. The discretion, ambiguity, and randomness were considered during the evaluation process, and a more scientific assessment fusion result of Decision makers (DMs) was obtained, while the Delphi iteration process further reduced personal errors. A case study of an oil depot in Dalian was investigated. The results showed that the proposed method more accurately identified the weak links in the safety system, providing a theoretical basis for the risk prevention and control. [ABSTRACT FROM AUTHOR]

European food laws increasingly use scientific evidence to protect consumers from hazards and to prevent the use of misleading information. In this article, the use of risk assessment in European food law is analysed and the implications of the recently adopted adjustments to the EU's General Food Law are reviewed. The risk analysis cycle that has been implemented in many authorisation decisions of the European Commission has resulted in the increased level of public health protection since 2002. The food law evaluation under REFIT however identified various shortcomings, including the civil societies' perception that various elements of EFSA's work lacked transparency and independence. To deal with these identified issues, the newly adopted regulation will bring about specific adjustments to the General Food Law and sectorial legislation. Although these adjustments are expected to improve European food policies, today's EU food laws should be further enhanced by improving the use of nutritional sciences in food law. Such joint efforts can result in a higher level of consumer protection and further advance the internal European market. Only through improving the systematic way to conduct scientific analyses into and by enhancing their use in risk management, European food law will become more future-proof. • REFIT identified the current risk assessment procedure as not being future proof. • Scientific assessment more accurately describes EFSA's work than risk assessment. • Improving transparency of risk assessment alone cannot lead to complete protection. • More systematic scientific assessments will aid in ensuring consumer protection. [ABSTRACT FROM AUTHOR]

The Genetics Panel of the National Academy of Sciences' Committee on Biological Effects of Atomic Radiation (BEAR) recommended the adoption of the linear dose-response model in 1956, abandoning the threshold dose-response for genetic risk assessments. This recommendation was quickly generalized to include somatic cells for cancer risk assessment and later was instrumental in the adoption of linearity for carcinogen risk assessment by the Environmental Protection Agency. The Genetics Panel failed to provide any scientific assessment to support this recommendation and refused to do so when later challenged by other leading scientists. Thus, the linearity model used in cancer risk assessment was based on ideology rather than science and originated with the recommendation of the NAS BEAR Committee Genetics Panel. Historical documentation in support of these conclusions is provided in the transcripts of the Panel meetings and in previously unexamined correspondence among Panel members. [ABSTRACT FROM AUTHOR]

This article discusses how the U. S. Environmental Protection Agency (EPA) uses input from the public on defaults, extrapolation assumptions, and uncertainty factors in risk assessment. According to the author risk assessment as practiced by the (EPA), defaults are necessary and useful, but their use must follow science policy and must be explicitly described. It was suggested that the USEPA must not intermingle policy judgments within the scientific assessment of risk. Risk assessments should acknowledge the presence of considerable uncertainty. Risk assessments should not rely on conservative ("worst case") assumptions that distort outcomes and yield estimates that grossly overstate risk.

Physically based models have been widely used around the world to study landslide occurrence. The accuracy in a physically based landslide susceptibility/hazard assessment depends mostly on the input parameters. In this research study, three physically based models' applicability and performance were assessed using deterministic and probabilistic approaches. It was carried out in a data-scarce environment: a tropical mountain basin of the Colombian Andes. TRIGRS, SLIP and Iverson models were applied with back analysis of the landslide events in the La Liboriana basin on May 18, 2015. The performance of the models was evaluated using ROC (receiver operating characteristic) analysis and %LR class index. The results showed that the back analysis using landslide events could be a good alternative to define the input parameters for physically based models in data-scarce tropical mountain areas. The ROC analysis and %LR class are considered useful techniques for assessing landslide modeling performance. The metric indices calculated should be seen as complementary information, and the drawbacks of these indices should be identified, as elucidated in this paper. • Landslide simulations of the May 18, 2015 La Liboriana landslide events were done. • Assessing landslides with back analysis is a valuable tool in data-scarce environments. • ROC analysis and %LR class were used to evaluate the modeling predictability. • Iverson, SLIP and TRIGRS models had a good performance in a tropical mountain basin. [ABSTRACT FROM AUTHOR]