Women and Migration : A phenomenological study of the successful acculturation process

The aim of this phenomenological research was to study immigrant women with satisfactory lives and to explore their emotions, impressions, thoughts and experiences of a cultural transition to gain more insight in how they have managed to deal with the initial acculturation process. An open question was sent to the participants (n=8) via e-mail, and the self-reports were analyzed with MCA-Minerva (Meaning Constitution Analysis). One main finding showed the importance of interaction and the acculturation strategies used by the immigrant as well as by the host majority for the relational outcomes. The outcomes in this study can serve as an initial step towards a better understanding of the successfully acculturated female immigrant's situation and might give implications that could be further investigated through future research

Sources of exposure to Bisphenol A

In July 2010 the Swedish government commissioned the Swedish Chemicals Agency (KemI) to investigate the need as well as possible conditions for a national ban on bisphenol A (BPA) in certain plastic products. The investigation was carried out in collaboration with the Swedish Food Administration (SLV). As part of the investigation KemI asked the instiutet of Environmental Medicine (IMM) at Karolinska institutet to review and evaluate the available literature on exposure to BPA from different products. The report presents the result of that review. The purpose of this report is to summerize information on potential sources of exposure to BPA in the general population. Available scientific literature relevant to the investigation, as well as risk assessment documents from different authorities and expert groups was reveiwd. Additional expertise concerning dermal uptake and exposure has been kindly provided by Professor Gunnar Johanson at IMM. Some conculsions about which exposure source seem to be the most significant are made. However, it is beyond the scope of this investigation to provide a complete exposure assessment for BPA. Data gaps and future research needs are presented

Development of the SciRAP Approach for Evaluating the Reliability and Relevance of in vitro Toxicity Data

Efficient and successful integration of data generated from non-animal test methods must rely on reliable and relevant data. It is important therefore to develop tools and criteria that facilitate scientifically sound, structured, and transparent evaluation of reliability and relevance of in vitro toxicity data to efficiently inform regulatory hazard and risk assessment. The Science in Risk Assessment and Policy (SciRAP) initiative aims to promote such overarching goals. We present the work to develop and refine the SciRAP tool for evaluation of reliability and relevance of in vitro studies for incorporation on the SciRAP web-based platform ( www.scirap.org ). In the SciRAP approach, reliability evaluation is based on criteria for reporting quality and methodological quality, and is explicitly separated from relevance evaluation. The SciRAP in vitro tool (version 1.0) was tested and evaluated during an expert test round (April 2019-September 2020) on three in vitro studies by thirty-one experts from regulatory authorities, industry and academia from different geographical areas and with various degree of experience in in vitro research and/or human health risk assessment. In addition, the experts answered an online survey to collect their feedback about the general features and desired characteristics of the tool for further refinement. The SciRAP in vitro tool (version 2.0) was revised based on the outcome of the expert test round (study evaluation and online survey) and consists of 24 criteria for evaluating " reporting quality " (reliability), 16 criteria for " methodological quality " (reliability) , and 4 items for evaluating relevance of in vitro studies. Participants were generally positive about the adequacy, flexibility, and user-friendliness of the tool. The expert test round outlined the need to (i) revise the formulation of certain criteria; (ii) provide new or revised accompanying guidance for reporting quality and methodological quality criteria in the " test compounds and controls ," " test system ," and " data collection and analysis " domains; and (iii) provide revised guidance for relevance items, as general measures to reduce inter-expert variability. The SciRAP in vitro tool allows for a structured and transparent evaluation of in vitro studies for use in regulatory hazard and risk assessment of chemicals

Risk Assessment of Endocrine Disrupting Compounds

During the past decade a growing number of chemicals have been identified as having endocrine disrupting properties in laboratory studies. Also, associations between exposure to such substances and endocrine-related health effects in the general population, as well as in wildlife, have been increasingly reported. This implies that past chemical regulation has failed to adequately protect human health and the environment. Endocrine disrupting compounds (EDCs) have lately been identified as substances of very high concern that should be phased out in new European (EU) legislations for e.g. industrial chemicals, plant protection products and biocides. There is thus an increased pressure on regulatory agencies to be able to efficiently and reliably identify, characterize and risk assess EDCs. However, risk assessment of EDCs has proven complicated, in part due to the complex toxicity exhibited by substances that can interact with the endocrine system, and also because there are currently no generally agreed upon criteria within the EU or internationally that direct how to specifically identify compounds with endocrine disrupting properties. The aim of this thesis project has been to identify how scientific uncertainties concerning the toxicity of EDCs can be reduced or handled to make health risk assessments of EDCs more transparent, systematic, and reliable. To that end literature studies were conducted that investigated the risk assessment process for EDCs within different regulatory frameworks in the EU, as well as the underlying toxicity data available to risk assessors and how the use of all available toxicity data can be improved. The much debated EDC bisphenol A (BPA) was used for a case study in a large part of this work. A comparison of different regulatory frameworks within the EU showed that the regulatory risk assessment process, including underlying policies, criteria and requirements may differ for EDCs belonging to different regulatory groups, e.g. industrial chemicals, plant protection products or pharmaceuticals. The investigations within this project also showed that non-standard research studies, i.e. studies not conducted according to standardized regulatory test guidelines, fill data gaps and contribute information that could be particularly important for the identification and risk assessment of EDCs. However, non-standard studies were often criticized for having methodological limitations or being insufficiently reported, limiting their use in regulatory risk assessment. Regulatory agencies commonly gave more weight to standard than non-standard studies in risk assessment of BPA, despite the growing amount of research indicating that toxic effects at low doses were being overlooked. A framework of criteria and guidelines intended to enable transparent and systematic evaluation of non-standard research studies, as well as guidance for how to report in vivo research to meet the requirements for regulatory risk assessment, was proposed. These tools are intended to facilitate the use of non-standard research studies in regulatory risk assessment and hopefully improve the reliability of risk assessment conclusions for EDCs

Deliverable 9.1 - Report on mixtures and implementation strategy in Europe – Assessment of chemical mixtures under consideration of current and future regulatory requirements and scientific approaches

This report gives an overview on the regulatory processes and requirements for risk assessment of chemical mixtures, identifies gaps in the European legislation and summarises potential approaches for the health risk assessment of chemical mixtures

Beyond chemicals: opportunities and challenges of integrating non-chemical stressors in adverse outcome pathways

The adverse outcome pathways (AOPs) were developed to accelerate evidence-based chemical risk assessment by leveraging data from new approach methodologies. Thanks to their stressor-agnostic approach, AOPs were seen as instrumental in other fields. Here, we present AOPs that report non-chemical stressors along with the challenges encountered for their development. Challenges regarding AOPs linked to nanomaterials include non-specific molecular initiating events, limited understanding of nanomaterial biodistribution, and needs for adaptations of the in silico modeling and testing systems. Development of AOPs for radiation face challenges in how to incorporate ionizing events type, dose rate, energy deposition, and how to account for targeting multiple macromolecules. AOPs for COVID-19 required the inclusion of SARS-CoV-2-specific replicative steps to capture the essential events driving the disease. Developing AOPs to evaluate efficacy and toxicity of cell therapies necessitates addressing the cellular nature and the therapeutic function of the stressor. Finally, addressing toxicity of emerging biological stressors like microbial pesticides can learn from COVID-19 AOPs. We further discuss that the adaptations needed to expand AOP applicability beyond chemicals are mainly at the molecular and cellular levels while downstream key events at tissue or organ level, such as inflammation, are shared by many AOPs initiated by various stressors. In conclusion, although it is challenging to integrate non-chemical stressors within AOPs, this expands opportunities to account for real-world scenarios, to identify vulnerable individuals, and to bridge knowledge on mechanisms of adversity.info:eu-repo/semantics/publishedVersio

A proposed framework for the systematic review and integrated assessment (SYRINA) of endocrine disrupting chemicals

Background - The issue of endocrine disrupting chemicals (EDCs) is receiving wide attention from both the scientific and regulatory communities. Recent analyses of the EDC literature have been criticized for failing to use transparent and objective approaches to draw conclusions about the strength of evidence linking EDC exposures to adverse health or environmental outcomes. Systematic review methodologies are ideal for addressing this issue as they provide transparent and consistent approaches to study selection and evaluation. Objective methods are needed for integrating the multiple streams of evidence (epidemiology, wildlife, laboratory animal, in vitro, and in silico data) that are relevant in assessing EDCs. Methods - We have developed a framework for the systematic review and integrated assessment (SYRINA) of EDC studies. The framework was designed for use with the International Program on Chemical Safety (IPCS) and World Health Organization (WHO) definition of an EDC, which requires appraisal of evidence regarding 1) association between exposure and an adverse effect, 2) association between exposure and endocrine disrupting activity, and 3) a plausible link between the adverse effect and the endocrine disrupting activity. Results - Building from existing methodologies for evaluating and synthesizing evidence, the SYRINA framework includes seven steps: 1) Formulate the problem; 2) Develop the review protocol; 3) Identify relevant evidence; 4) Evaluate evidence from individual studies; 5) Summarize and evaluate each stream of evidence; 6) Integrate evidence across all streams; 7) Draw conclusions, make recommendations, and evaluate uncertainties. The proposed method is tailored to the IPCS/WHO definition of an EDC but offers flexibility for use in the context of other definitions of EDCs. Conclusions - When using the SYRINA framework, the overall objective is to provide the evidence base needed to support decision making, including any action to avoid/minimise potential adverse effects of exposures. This framework allows for the evaluation and synthesis of evidence from multiple evidence streams. Finally, a decision regarding regulatory action is not only dependent on the strength of evidence, but also the consequences of action/inaction, e.g. limited or weak evidence may be sufficient to justify action if consequences are serious or irreversible.The workshops that supported the writing of this manuscript were funded by the Swedish Foundation for Strategic Environmental Research “Mistra”. LNV was funded by Award Number K22ES025811 from the National Institute of Environmental Health Sciences of the National Institutes of Health. TJW was funded by The Clarence Heller Foundation (A123547), the Passport Foundation, the Forsythia Foundation, the National Institute of Environmental Health Sciences (grants ES018135 and ESO22841), and U.S. EPA STAR grants (RD83467801 and RD83543301). JT was funded by the Academy of Finland and Sigrid Juselius. UH was funded by the Danish EPA. KAK was funded by the Canada Research Chairs program grant number 950–230607