RISK ASSESSMENT FOR BOVINE WELFARE AT SLAUGHTER. A COMPARISON BETWEEN A RISK ASSESSMENT BASED ON EMPIRICAL DATA AND A RISK ASSESSMENT BASED ON EXPERT OPINION

Background. Risk assessment is a systematic process that uses modelling to estimate the likelihood of adverse effects occurring from exposure to hazards. While risk assessment is widely used to support decision making in many areas of food and feed safety (e.g. veterinary epidemiology, toxicology, eco-toxicology), it is a relatively new concept for animal welfare. Currently there are no standardised guidelines for animal welfare risk assessment. Furthermore, very little research has been conducted to assess the reliability of the existing methods, which mostly rely on qualitative data and are based on expert opinion. Objectives. The objectives of this research project were to assess the scientific robustness of existing risk assessment methods for animal welfare and identify any potential methodological flaws of these processes. Methods. The currently available methods for animal welfare risk assessment were analysed in detail. Two risk assessments for beef cattle at slaughter (in northern Italy) were performed and compared. One based on empirical data (i.e. collected in slaughterhouses) and one based on expert opinion (gathered via a questionnaire submitted to a group of 11 experts). The two new risk assessments were structured to be as similar as possible to the animal welfare risk assessments under appraisal. A list of 56 hazards potentially relevant to beef cattle at slaughter was produced via a literature review. The relevance of such hazards was assessed by a series of preliminary observations in abattoirs and by asking the 11 experts to assess it. Fourteen hazards were excluded from the subsequent analyses as never being observed during the on-site observations and indicated as not relevant by at least 5 out 11 experts. For the risk assessment based on empirical data, a novel method for performing on-site exposure assessment and likelihood of the adverse effects (by severity levels) was developed. The method was based on a precise definition of the hazards and a differentiation between adverse welfare effects and measurable indicators of adverse effects. The latter were associated to different severity classes defined qualitatively on the basis of the intensity of the behavioural responses of the animals. In the second risk assessment the approach to eliciting expert opinion was different from the existing animal welfare risk assessments (based on consensus opinion) as the experts answered the questionnaire independently. Thorough a series of risk assessment-tailored questions, the experts were asked to assess hazard exposure (for beef cattle at slaughter in northern Italy), characterise the adverse effects resulting from the exposure to the hazards and indicate the related uncertainty. Exposure assessment based on empirical data and on expert opinion was compared for 42 hazards. As 18 hazards were never detected during the on-site observations (or the number of animals exposed was < 5), adverse effect characterisation and final risk were estimated and compared for 24 hazards. Results. The results of exposure assessment based on empirical data and on expert opinion were inconsistent for 24 out of 42 hazards. Consistent results for all possible adverse effects resulting from the exposure to a hazard never occurred. Often the variability between the experts\u2019 responses on exposure assessment and adverse effect characterisation was high. In line with the results of exposure assessment and adverse effect characterisation, the two risk estimates rarely produced comparable results. Discussion. The analysis of the available methods for animal welfare risk assessment performed in this study, the discordance of the results of the two risk assessments and the variability between the experts\u2019 responses highlighted some inherent flaws and requirements of existing risk assessments for animal welfare. A more detailed and measurable description of the hazards should be available. Further, a clear understanding of the animal welfare outcomes and their measurement is paramount. In addition, while performing the on-site observations it was clear that interactions between hazards and different hazards intensities and durations need more consideration. The method developed for performing on-site exposure assessment and estimating the likelihood of the adverse effects proved to be very valuable to solve most of the highlighted limitations of existing animal welfare risk assessments. Conclusions. A unique and useful approach to defining the hazards for animal welfare and to assessing animal welfare in a measurable and quantifiable way was developed. In particular the method for assessing animal welfare was based on a clear differentiation between adverse welfare effects and measurable indicators of poor welfare (classified by severity levels). This approach to hazard description and welfare outcome definition and assessment is recommended for enhancing empirical research on animal welfare especially when there is a lack of empirical data for risk assessment. Furthermore, this method can lead to a standardised and harmonised approach for the evaluation of hazards and adverse effects between experts, leading to more robust risk assessments. This study also proposed an alternative method for eliciting expert opinion based on independent scoring of the risk assessment parameters. The approach showed very useful implications for identifying sources of uncertainties that are normally overlooked in existing risk assessments for animal welfare, such as difficulties in assessing the risk assessment parameters, disagreements between the experts or lack of expert knowledge. Finally this study highlighted that, independently of the data used for the risk assessment (i.e. empirical data or expert opinion), the method for either reviewing the literature or gathering expert opinion should be chosen in light of the best available practices. The process and any decisions taken should be documented to ensure greater transparency and reproducibility

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

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment

Magnetic properties and EPR spectra of [Cu(L-arginine)2](NO3)2.3H2O

Magnetic and EPR data have been collected for complex [Cu(L-Arg)2](NO3)2-3H2O (Arg ¼ arginine). Magnetic susceptibility w in the temperature range 2–160 K, and a magnetization isotherm at T ¼ 2.29(1)K with magnetic fields between 0 and 9 T were measured. The observed variation of wT with T indicates predominant antiferromagnetic interactions between Cu(II) ions coupled in 1D chains along the b axis. Fitting a molecular field model to the susceptibility data allows to evaluate g ¼ 2.10(1) for the average g-factor and J ¼ -0.42(6) cm-1 for the nearest neighbor exchange coupling (defined as Hex ¼ -PJijSi- Sj). This coupling is assigned to syn–anti equatorial–apical carboxylate bridges connecting Cu(II) ion neighbors at 5.682A ° , with a total bond length of 6.989A ° and is consistent with the magnetization isotherm results. It is discussed and compared with couplings observed in other compounds with similar exchange bridges. EPR spectra at 9.77 were obtained in powder samples and at 9.77 and at 34.1GHz in the three orthogonal planes of single crystals. At both microwave frequencies, and for all magnetic field orientations a single signal arising from the collapse due to exchange interaction of resonances corresponding to two rotated Cu(II) sites is observed. From the EPR results the molecular g-tensors corresponding to the two copper sites in the unit cell were evaluated, allowing an estimated lower limit |J |40.1 cm-1 for the exchange interaction between Cu(II) neighbors, consistent with the magnetic measurements.Fil: Gerard, Matias Fernando. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Desarrollo Tecnológico para la Industria Química. Universidad Nacional del Litoral. Instituto de Desarrollo Tecnológico para la Industria Química; ArgentinaFil: Aiassa, C.. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; ArgentinaFil: Casado, Nieves Maria Claudia. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; ArgentinaFil: Santana, R. C.. Universidade Federal de Goiás; BrasilFil: Perec, Mireille. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Departamento de Química Inorgánica, Analítica y Química Física; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Rapp, R. E.. Universidade Federal do Rio de Janeiro; BrasilFil: Calvo, Rafael. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Desarrollo Tecnológico para la Industria Química. Universidad Nacional del Litoral. Instituto de Desarrollo Tecnológico para la Industria Química; Argentin