Weighing evidence and assessing uncertainties

Methodologies for integrating (weighing) evidence and assessing uncertainties are of utmost importance to ensure that scientific assessments are transparent, robust and fit for purpose to support decision-makers. One of the key challenges remains the development of harmonised methodologies for both weighing scientific evidence and assessing uncertainties in the food safety area mainly because of the multidisciplinary and complex nature of the topics involved. The breakout session 'Weighing evidence and assessing uncertainties' was held at the EFSA 2nd Scientific Conference 'Shaping the Future of Food Safety, Together'. This paper aims at summarising the contributions of this breakout session and formulates recommendations to further support the development of harmonised methodologies and practical applications for weighing evidence and analysing uncertainty in key areas of food safety, including chemical risk assessment, microbiological risk assessment and environmental risk assessment

Using scientific evidence to inform public policy on the long distance transportation of animals: role of the European Food Safety Authority

The authors review the work of the previous Scientific Committee on Animal Health and Animal Welfare and the current European Food Safety Authority (EFSA) in providing scientific advice on the welfare aspects of animal transport and the impact of this advice on the European Union (EU) regulatory framework. Through its Protocol on the Protection and Welfare of Animals, the Treaty of Amsterdam obliges European institutions to pay full regard to the welfare requirements of animals when formulating and implementing EU legislation. Regulation 1/2005 states that EU legislation should be amended to take into account new scientific evidence. Provisions for poultry, cats and dogs take into account the recommendations included in EFSA's Scientific Opinion which considers different species (poultry, deer, rabbits, dogs and cats, fish and exotic animals). Examples of the effect of the scientifically based conclusions and recommendations from the Scientific Opinion on the measures in Regulation 1/2005 are summarised and show the impact of scientific evidence on EU legislation

Update of environmental risk assessment conclusions and risk management recommendations of EFSA (2016) on EU teosinte

Abstract Teosinte, wild maize relatives originating from Mexico and Central America, emerged as a noxious agricultural weed in France and Spain. In 2016, the European Food Safety Authority (EFSA) issued a technical report that assessed the available scientific information on teosinte for its relevance for the environmental risk assessment (ERA) and risk management (RM) of genetically modified (GM) maize MON810, Bt11, 1507 and GA21 for cultivation. It was concluded that the impact of insect resistance and/or herbicide tolerance in GM teosinte hybrid progeny (potentially acquired through hybridisation between GM maize and teosinte) on target and non‐target organisms, the abiotic environment and biogeochemical cycles would be very low under EU conditions. Following a request of the European Commission, EFSA evaluated whether the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, or require revision in light of new scientific evidence on teosinte that has become available since the publication of EFSA (2016). A protocol was developed to clarify the interpretation of the terms of reference of the mandate and make them operational. The assessment relied on evidence retrieved via an extensive literature search and from reports of the Competent Authorities of France and Spain, and on hearing expert testimonies. A limited collection of 18 publications of varying relevance and quality was retrieved and assessed. Based on this evidence, it is concluded that the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, except those pertaining to the use of glyphosate‐based herbicides on maize GA21 which should be considered under Regulation (EC) No 1107/2009. In infested agricultural areas (especially in regions where maize MON810 is widely grown), weed management measures implemented to monitor, control and/or eradicate teosinte must remain in place, as they will contribute to further reduce the low vertical gene flow potential between GM maize and EU teosinte

Guidance on risk assessment for animal welfare

The document provides methodological guidance to assess risks for animal welfare, considering the various husbandry systems, management procedures and the different animal welfare issues. The terminology for the risk assessment of animal welfare is described. Risk assessment should not be carried out unless the relevant welfare problem is clearly specified and formulated. The major components of the problem formulation are the description of the exposure scenario, the target population and the conceptual model linking the relevant factors of animal welfare concern. The formal risk assessment consists of exposure assessment, consequence characterisation, and risk characterisation. The systematic evaluation of the various aspects and components of the assessment procedure aims at ensuring its consistency. All assumptions used in problem formulation and risk assessment need to be clear. This also applies to uncertainty and variability in the various steps of the risk assessment. The choice between qualitative, semi-qualitative or quantitative approaches should be made based on the purpose or the type of questions to be answered, data, and resource availability for a specific risk assessment. Quantitative data should be used whenever possible. Positive effects on welfare (benefit) could be handled within the framework of risk assessment if the analysis considers factors as having both positive and negative effects on animal welfare. The last section details the main components of risk assessment documentation

Risk assessment in animal welfare : EFSA approach

Animal Welfare (AW) issues are becoming an increasing concern for food-producing and laboratory animals. Risk Assessment (RA) is usually used to describe and quantify the risk of introduction of infections, toxiinfections or residues coming from veterinary medicines, by importing live animals and their products or to identify options for the control of epidemic or endemic diseases. Recently, RA methods have been sought to be applied to AW as well. However, considering that this is a newly emerging area, for which no general guidelines have been produced, the above mentioned RAs cannot be always directly transferred. The use of a RA approach to evaluate issues related to AW can be useful to better identify and rank welfare risk factors, and to prioritise possible management measures. Possible approaches to AW RA are described and differences and similarities with the classical RA are discussed as well as the problems identified concerning the use of RA methodology for AW. A significant difficulty in AW RA consists in the quantification of the severity and of the probability of exposure of the identified hazards to welfare. Furthermore, data from different expert opinions are not always expressed using the same scale. The European Food Safety Authority (EFSA) has launched RA studies in which AW was considered as endpoint of interest. Examples are briefly discusse

Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks

The workshop titled “Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks” was co-organized by the Evidence-based Toxicology Collaboration and the European Food Safety Authority (EFSA) and hosted by EFSA at its headquarters in Parma, Italy on October 2 and 3, 2019. The goal was to explore integration of systematic review with mechanistic evidence evaluation. Participants were invited to work on concrete products to advance the exploration of how evidence-based approaches can support the development and application of adverse outcome pathways (AOP) in chemical risk assessment. The workshop discussions were centered around three related themes: 1) assessing certainty in AOPs, 2) literature-based AOP development, and 3) integrating certainty in AOPs and non-animal evidence into decision frameworks. Several challenges, mostly related to methodology, were identified and largely determined the workshop recommendations. The workshop recommendations included the comparison and potential alignment of processes used to develop AOP and systematic review methodology, including the translation of vocabulary of evidence-based methods to AOP and vice versa, the development and improvement of evidence mapping and text mining methods and tools, as well as a call for a fundamental change in chemical risk and uncertainty assessment methodology if to be conducted based on AOPs and new approach methodologies (NAM). The usefulness of evidence-based approaches for mechanism-based chemical risk assessments was stressed, particularly the potential contribution of the rigor and transparency inherent to such approaches in building stakeholders’ trust for implementation of NAM evidence and AOPs into chemical risk assessment.publishe

Silver nanoparticles from leafy green extract of Belgian endive (Cichorium intybus L. var. sativus): Biosynthesis, characterization, and antibacterial activity

We report for the first time a green, simple, and low-cost synthesis of silver nanoparticles (AgNPs) by mixing AgNO3 solution with the aqueous leaf extract of Belgian endive, a variety of Cichorium intybus L., without any harmful reducing and capping agents. The biosynthesis of AgNPs was observed by the color charge from colorless (metal salt solution) to a yellowish brown (nanoparticle colloidal dispersion), which was confirmed by UV–vis spectroscopy, transmission electron microscopy (TEM), and X-ray diffraction (XRD). UV–vis spectra showed the surface plasmon resonance signature of AgNPs around 420 nm, TEM revealed that nanoparticles were quasi-spherical with an average diameter ranging from 19 to 64 nm depending on the metal salt concentration, and XRD pattern indicated that the biosynthetic process produced face-centered cubic AgNPs. Surface-enhanced Raman spectroscopy analysis showed that the AgNPs were capped with bioactive molecules from the leaf extract, which are also believed to be responsible for the bio-reduction of silver ions. The antibacterial activity of the biosynthesized AgNPs was studied using both the disk diffusion and minimum inhibitory concentration methods against Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa, and they were found to be effective at picomolar concentration levels.Fil: Gallucci, Mauro Nicolas. Universidad Nacional de Santiago del Estero. Instituto de Bionanotecnología del Noa. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Instituto de Bionanotecnología del Noa; ArgentinaFil: Fraire, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Investigaciones en Físico-química de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Investigaciones en Físico-química de Córdoba; ArgentinaFil: Ferreyra Maillard, Anike Paula Virginia. Universidad Nacional de Santiago del Estero. Instituto de Bionanotecnología del Noa. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Instituto de Bionanotecnología del Noa; ArgentinaFil: Páez, Paulina Laura. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Aiassa Martínez, Ivana María. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Pannunzio Miner, Elisa Victoria. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Investigaciones en Físico-química de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Investigaciones en Físico-química de Córdoba; ArgentinaFil: Coronado, Eduardo A.. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Investigaciones en Físico-química de Córdoba. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Instituto de Investigaciones en Físico-química de Córdoba; ArgentinaFil: Dalmasso, Pablo Roberto. Universidad Nacional de Santiago del Estero. Instituto de Bionanotecnología del Noa. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Instituto de Bionanotecnología del Noa; Argentin

Guidance on protocol development for EFSA generic scientific assessments

Abstract EFSA Strategy 2027 outlines the need for fit‐for‐purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ‘Draft framework for protocol development for EFSA's scientific assessments’ published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub‐questions is proposed: the ‘APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross‐cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub‐questions, including uncertainty analysis. Five possible approaches to answering individual (sub‐)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi‐formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and – not covered in this guidance – generating empirical evidence ex novo. The guidance is complemented by a standalone ‘template’ for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment

Implementation of PROMETHEUS 4‐step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions

In 2014, the European Food Safety Authority (EFSA) started the PROMETHEUS (PROmoting METHods for Evidence Use in Scientific assessments) project to improve further and increase the consistency of the methods it uses in its scientific assessments. The project defined a set of principles for the scientific assessment process and a 4‐step approach (plan/carry out/verify/report) for their fulfilment, which was tested in ten case studies, one from each EFSA panel. The present report describes the benefits, issues, needs and solutions related to the implementation of the 4‐step approach in EFSA, identified in a dedicated workshop in October 2017. The key benefits of the approach, which was deemed applicable to all types of EFSA scientific assessment including assessments of regulated products, are: 1) increased ‘scientific value’ of EFSA outputs, i.e. the extent of impartiality, methodological rigour, transparency and engagement; 2) guarantee of fitness‐for‐purpose, as it implies tailoring the methods to the specificities of each assessment; 3) efficiency gain, since preparing a protocol for the assessment upfront helps more streamlined processes throughout the implementation phase; 4) innovation, as the approach promotes the pioneering practice of ‘planning before doing’ (well established in primary research) for broad scientific assessments in regulatory science; and 5) increased harmonisation and consistency of EFSA assessments. The 4‐step approach was also considered an effective system for detecting additional methodological and/or expertise needs and a useful basis for further defining a quality management system for EFSA's scientific processes. The identified issues and solutions related to the implementation of the approach are: a) lack of engagement and need for effective communication on benefits and added value; b) need for further advances especially in the field of problem formulation/protocol development, evidence appraisal and evidence integration; c) need for specialised expertise in the previous aspects; and specific needs for d) assessments of regulated products and e) outsourced projects