Technical assistance in the field of risk communication.

This report assesses peer-reviewed and grey literature on risk communication concepts and practices, as requested by the European Commission to support the implementation of a 'General Plan for Risk Communication', i.e. an integrated framework for EU food safety risk assessors and risk managers at Union and national level, as required by the revised EU General Food Law Regulation. We conducted a scoping review of social research studies and official reports in relation to risk communication in the following areas: understanding and awareness of risk analysis roles and tasks, reducing misunderstanding of the different meaning of the terms 'hazard' and 'risk', tackling misinformation and disinformation, enhancing confidence in EU food safety, taking account of risk perceptions, key factors in trade-offs about risks, audience segmentation and tools, channels and mechanisms for coordinated risk communications. We structured our findings as follows: i) definitions of key concepts, ii) audience analysis and information requirements, iii) risk profiling, models and mechanisms, iv) contributions to communication strategies. We make several recommendations for consideration by the Commission, both in terms of actions to support the design and implementation of the general plan, and research needs that we consider crucial to further inform appropriate risk communication in the EU. EFSA carried out a targeted consultation of experts and a public consultation open to all interested parties including the general public, in preparing and finalising this report.

Guidance on Communication of Uncertainty in Scientific Assessments.

This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: 'Guidance on uncertainty analysis in scientific assessments'. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The guidance is structured according to EFSA's three broadly defined categories of target audience: 'entry', 'informed' and 'technical' levels. Communicators should use the guidance for entry and informed audiences, while assessors should use the guidance for the technical level. The guidance was formulated using evidence from the scientific literature, grey literature and two EFSA research studies, or based on judgement and reasoning where evidence was incomplete or missing. The limitations of the evidence sources inform the recommendations for further research on uncertainty communication.

Comparison of methods for calculating the health costs of endocrine disrupters: a case study on triclosan.

BACKGROUND: Socioeconomic analysis is currently used in the Europe Union as part of the regulatory process in Regulation Registration, Evaluation and Authorisation of Chemicals (REACH), with the aim of assessing and managing risks from dangerous chemicals. The political impact of the socio-economic analysis is potentially high in the authorisation and restriction procedures, however, current socio-economic analysis dossiers submitted under REACH are very heterogeneous in terms of methodology used and quality. Furthermore, the economic literature is not very helpful for regulatory purposes, as most published calculations of health costs associated with chemical exposures use epidemiological studies as input data, but such studies are rarely available for most substances. The quasi-totality of the data used in the REACH dossiers comes from toxicological studies. METHODS: This paper assesses the use of the integrated probabilistic risk assessment, based on toxicological data, for the calculation of health costs associated with endocrine disrupting effects of triclosan. The results are compared with those obtained using the population attributable fraction, based on epidemiological data. RESULTS: The results based on the integrated probabilistic risk assessment indicated that 4894 men could have reproductive deficits based on the decreased vas deferens weights observed in rats, 0 cases of changed T3 levels, and 0 cases of girls with early pubertal development. The results obtained with the Population Attributable Fraction method showed 7,199,228 cases of obesity per year, 281,923 girls per year with early pubertal development and 88,957 to 303,759 cases per year with increased total T3 hormone levels. The economic costs associated with increased BMI due to TCS exposure could be calculated. Direct health costs were estimated at €5.8 billion per year. CONCLUSIONS: The two methods give very different results for the same effects. The choice of a toxicological-based or an epidemiological-based method in the socio-economic analysis will therefore significantly impact the estimated health costs and consequently the political risk management decision. Additional work should be done for understanding the reasons of these significant differences.

A systematic review of methods of uncertainty analysis and their applications in the assessment of chemical exposures, effects, and risks.

Methods of uncertainty analysis are being included increasingly in regulatory chemical risk assessment. Although best practices have been established by several safety agencies in Europe and the United States, they exist only in the grey literature - there has been no comprehensive analysis of the scientific, peer-reviewed literature on these methods. We therefore conducted a systematic review of the recent peer-reviewed literature (2007-2013) on uncertainty analysis relevant to chemical risks. The main objective was to determine whether current methods are robust enough for regulatory use, because the methods used to protect public health must meet the most stringent scientific standards. Based on 297 papers, we concluded that the peer-reviewed literature is much more critical about the disadvantages of those methods, compared to the grey literature. Furthermore, uncertainty analyses can be influenced significantly by subjective expert judgment. As a suggested improvement, we developed guidelines for transparent reporting of uncertainty assessment results.

Machine learning-based detection of chemical risk.

Chemical risk appears with chemical substances that are dangerous for human or animal health, or for environment, such as with Bisphenol A and phtalates. Chemical risk causes several severe health disorders and is particularly dangerous for human health. Specific agencies are involved in the verification of the suitability of products and goods to be marketed. For this, a large amount of scientific and institutional literature is manually analyzed to study the current knowledge on the associated chemical risk. We propose to use machine learning and dedicated classification for the automatic detection of chemical risk statements. We test several algorithms and features and obtain between 0.60 and 0.95 F-measure.

Qualichem in vivo: a tool for assessing the quality of in vivo studies and its application for bisphenol A.

In regulatory toxicology, quality assessment of in vivo studies is a critical step for assessing chemical risks. It is crucial for preserving public health studies that are considered suitable for regulating chemicals are robust. Current procedures for conducting quality assessments in safety agencies are not structured, clear or consistent. This leaves room for criticism about lack of transparency, subjective influence and the potential for insufficient protection provided by resulting safety standards. We propose a tool called "Qualichem in vivo" that is designed to systematically and transparently assess the quality of in vivo studies used in chemical health risk assessment. We demonstrate its use here with 12 experts, using two controversial studies on Bisphenol A (BPA) that played an important role in BPA regulation in Europe. The results obtained with Qualichem contradict the quality assessments conducted by expert committees in safety agencies for both of these studies. Furthermore, they show that reliance on standardized guidelines to ensure scientific quality is only partially justified. Qualichem allows experts with different disciplinary backgrounds and professional experiences to express their individual and sometimes divergent views-an improvement over the current way of dealing with minority opinions. It provides a transparent framework for expressing an aggregated, multi-expert level of confidence in a study, and allows a simple graphical representation of how well the study integrates the best available scientific knowledge. Qualichem can be used to compare assessments of the same study by different health agencies, increasing transparency and trust in the work of expert committees. In addition, it may be used in systematic evaluation of in vivo studies submitted by industry in the dossiers that are required for compliance with the REACH Regulation. Qualichem provides a balanced, common framework for assessing the quality of studies that may or may not be following standardized guidelines.

Uncertainty: cause or effect of stakeholders' debates? Analysis of a case study: the risk for honeybees of the insecticide Gaucho.

The social construction of uncertainty plays a major role in environmental decision-making. Methods for assessing this aspect of scientific knowledge quality are lacking. Our analysis of the French debate on the risk that the insecticide Gaucho (active substance: imidacloprid) forms for honeybees is particularly relevant to this theoretical and practical gap. Based on our analysis, we propose six knowledge quality criteria that can assist in assessing the information communicated in an argumentative public process: reliability of the information - it must be based on all available scientific knowledge; robustness of the information - it must take into account criticism; use of the information produced by other stakeholders; relevancy of the arguments for issue under debate; logical coherence of the discourse; and legitimacy of the information source. Further, our findings deepen the understanding of the relationships between the social, economic, and institutional stakes of the actors involved in the debate and their strategies of 'creating uncertainty'. Finally, we compare the findings of this case study with the twelve lessons drafted by the European Environmental Agency (EEA) in its report Late lessons from early warnings, and we draft two more lessons. These lessons can be applied to future policy in order to minimize the repetition of past mistakes.