| 1. |
- Beronius, Anna, et al.
(author)
-
Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals : a proposal to improve evaluation criteria and reporting
- 2014
-
In: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 34:6, s. 607-617
-
Journal article (peer-reviewed)abstract
- To improve data availability in health risk assessment of chemicals and fill information gaps there is a need to facilitate the use of non-standard toxicity studies, i.e. studies not conducted according to any standardized toxicity test guidelines. The purpose of this work was to propose criteria and guidance for the evaluation of reliability and relevance of non-standard in vivo studies, which could be used to facilitate systematic and transparent evaluation of such studies for health risk assessment. Another aim was to propose user friendly guidance for reporting of non-standard studies intended to promote an improvement in reporting of studies that could be of use in risk assessment. Requirements and recommendations for the design and execution of in vivo toxicity studies were identified from The Organisation for Economic Co-operation and Development (OECD) test guidelines, and served as basis for the data evaluation criteria and reporting guidelines. Feedback was also collected from experts within the field of toxicity testing and risk assessment and used to construct a two-tiered framework for study evaluation, as well as refine the reporting guidelines. The proposed framework emphasizes the importance of study relevance and an important aspect is to not completely dismiss studies from health risk assessment based on very strict criteria for reliability. The suggested reporting guidelines provide researchers with a tool to fulfill reporting requirements as stated by regulatory agencies. Together, these resources provide an approach to include all relevant data that may fill information gaps and reduce scientific uncertainty in health risk assessment conclusions, and subsequently also in chemical policy decisions.
|
|
| 2. |
- Beronius, Anna, et al.
(author)
-
Testing and refining the Science in Risk Assessment and Policy (SciRAP) web-based platform for evaluating the reliability and relevance of in vivo toxicity studies
- 2018
-
In: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 38:12, s. 1460-1470
-
Journal article (peer-reviewed)abstract
- The Science in Risk Assessment and Policy (SciRAP) web-based platform was developed to promote and facilitate structure and transparency in the evaluation of ecotoxicity and toxicity studies for hazard and risk assessment of chemicals. The platform includes sets of criteria and a colour-coding tool for evaluating the reliability and relevance of individual studies. The SciRAP method for evaluating in vivo toxicity studies was first published in 2014 and the aim of the work presented here was to evaluate and develop that method further. Toxicologists and risk assessors from different sectors and geographical areas were invited to test the SciRAP criteria and tool on a specific set of in vivo toxicity studies and to provide feedback concerning the scientific soundness and user-friendliness of the SciRAP approach. The results of this expert assessment were used to refine and improve both the evaluation criteria and the colour-coding tool. It is expected that the SciRAP web-based platform will continue to be developed and enhanced to keep up to date with the needs of end-users.
|
|
| 3. |
- Hammar, Linus, 1979, et al.
(author)
-
A Probabilistic Model for Hydrokinetic Turbine Collision Risks: Exploring Impacts on Fish
- 2015
-
In: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203 .- 1932-6203. ; 10:3, s. e0117756-
-
Journal article (peer-reviewed)abstract
- A variety of hydrokinetic turbines are currently under development for power generation in rivers, tidal straits and ocean currents. Because some of these turbines are large, with rapidly moving rotor blades, the risk of collision with aquatic animals has been brought to attention. The behavior and fate of animals that approach such large hydrokinetic turbines have not yet been monitored at any detail. In this paper, we conduct a synthesis of the current knowledge and understanding of hydrokinetic turbine collision risks. The outcome is a generic fault tree based probabilistic model suitable for estimating population-level ecological risks. New video-based data on fish behavior in strong currents are provided and models describing fish avoidance behaviors are presented. The findings indicate low risk for small sized fish. However, at large turbines (≥5 m), bigger fish seem to have high probability of collision, mostly because rotor detection and avoidance is difficult in low visibility. Risks can therefore be substantial for vulnerable populations of large-sized fish, which thrive in strong currents. The suggested collision risk model can be applied to different turbine designs and at a variety of locations as basis for case-specific risk assessments. The structure of the model facilitates successive model validation, refinement and application to other organism groups such as marine mammals.
|
|
| 4. |
- Hammar, Linus, 1979, et al.
(author)
-
Hydrokinetic Turbine Effects on Fish Swimming Behaviour
- 2013
-
In: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203 .- 1932-6203. ; 8:12, s. artikel nr e84141-
-
Journal article (peer-reviewed)abstract
- Hydrokinetic turbines, targeting the kinetic energy of fast-flowing currents, are under development with some turbinesalready deployed at ocean sites around the world. It remains virtually unknown as to how these technologies affectfish, and rotor collisions have been postulated as a major concern. In this study the effects of a vertical axishydrokinetic rotor with rotational speeds up to 70 rpm were tested on the swimming patterns of naturally occurringfish in a subtropical tidal channel. Fish movements were recorded with and without the rotor in place. Results showedthat no fish collided with the rotor and only a few specimens passed through rotor blades. Overall, fish reduced theirmovements through the area when the rotor was present. This deterrent effect on fish increased with current speed.Fish that passed the rotor avoided the near-field, about 0.3 m from the rotor for benthic reef fish. Large predatory fishwere particularly cautious of the rotor and never moved closer than 1.7 m in current speeds above 0.6 ms-1. Theeffects of the rotor differed among taxa and feeding guilds and it is suggested that fish boldness and body shapeinfluenced responses. In conclusion, the tested hydrokinetic turbine rotor proved non-hazardous to fish during theinvestigated conditions. However, the results indicate that arrays comprising multiple turbines may restrict fishmovements, particularly for large species, with possible effects on habitat connectivity if migration routes areexploited. Arrays of the investigated turbine type and comparable systems should therefore be designed with gaps ofseveral metres width to allow large fish to pass through. In combination with further research the insights from thisstudy can be used for guiding the design of hydrokinetic turbine arrays where needed, so preventing ecologicalimpacts.
|
|
| 5. |
- Hammar, Linus, 1979, et al.
(author)
-
Stereo-Video Methodology for Quantitative Analysis of Fish-Turbine Interactions
- 2012
-
In: 1st Asian Wave and Tidal Conference Series. ; , s. 8-
-
Conference paper (peer-reviewed)abstract
- Tidal power turbines are developed to reach the ambition of supplying coastal communities with renewable energy. However, little is still known about the potential environmental effects on the local ecosystems and what rotor design can do to minimize such effects. The knowledge gap includes fish behavior around tidal power rotors and adequate sampling techniques for such studies. In this contribution stereo-video methodology has been used for monitoring fish movements at an operating model of a vertical-axis tidal turbine rotor. The results show that stereo-video methodology offers excellent opportunities for detailed analysis of fish behavior and several recommendations of how to optimize such sampling are provided. Preliminary results of fish-turbine interactions are presented.
|
|
| 6. |
- Hansson, Sven Ove, et al.
(author)
-
The substitution principle
- 2011
-
In: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 59:3, s. 454-460
-
Journal article (peer-reviewed)abstract
- According to the substitution principle, hazardous chemicals should be replaced by less hazardous alternatives. In this paper, the major issues concerning the more precise definition of the principle are analyzed, and a general purpose definition is proposed. It is claimed that the priority between reducing hazard, functionality and economical considerations in the application of the substitution principle is a matter for adjustment in each particular case that cannot be settled beforehand. None of these objectives can have absolute priority over the others, but the substitution principle is aimed at increasing the priority given to the reduction of hazards to human health and the environment. Major methods to promote and implement the principle are summarized, current legislative approaches are discussed, and proposals for efficient implementation are made. It is emphasized that the primary responsibility for avoiding hazardous substances and processes rests with industry.
|
|
| 7. |
- Molander, Linda, et al.
(author)
-
Are chemicals in articles an obstacle for reaching environmental goals? : Missing links in eu chemical management
- 2012
-
In: Science of the Total Environment. - : Elsevier BV. - 0048-9697 .- 1879-1026. ; 435, s. 280-289
-
Journal article (peer-reviewed)abstract
- It is widely acknowledged that the management of risks associated with chemicals in articles needs to be improved. The EU environmental policy states that environmental damage should be rectified at source. It is therefore motivated that the risk management of substances in articles also takes particular consideration to those substances identified as posing a risk in different environmental compartments. The primary aim of the present study was to empirically analyze to what extent the regulation of chemicals in articles under REACH is coherent with the rules concerning chemicals in the Sewage Sludge Directive (SSD) and the Water Framework Directive (WFD). We also analyzed the chemical variation of the organic substances regulated under these legislations in relation to the most heavily used chemicals. The results show that 16 of 24 substances used in or potentially present in articles and regulated by the SSD or the WFD are also identified under REACH either as a substance of very high concern (SVHC) or subject to some restrictions. However, for these substances we conclude that there is limited coherence between the legislations, since the identification as an SVHC does not in itself encompass any use restrictions, and the restrictions in REACH are in many cases limited to a particular use, and thus all other uses are allowed. Only a minor part of chemicals in commerce is regulated and these show a chemical variation that deviates from classical legacy pollutants. This warrants new tools to identify potentially hazardous chemicals in articles. We also noted that chemicals monitored in the environment under the WFD deviate in their chemistry from the ones regulated by REACH. In summary, we argue that to obtain improved resource efficiency and a sustainable development it is necessary to minimize the input of chemicals identified as hazardous to health or the environment into articles.
|
|
| 8. |
- Molander, Linda, 1984-
(author)
-
Chemicals in consumer products : Towards a safe and sustainable use
- 2012
-
Licentiate thesis (other academic/artistic)abstract
- Health and environmental risks associated with emissions of hazardous chemicals from articles, including everyday consumer products such as clothes and toys, have become widely acknowledged internationally, particularly in the EU. This thesis contributes to new understandings of how these risks are currently managed within the EU and recommends actions for ensuring a safe and sustainable use of chemicals in articles.Paper I provides an overview and comparative analysis of regulatory strategies for managing risks of chemicals in articles in the EU. The in-depth analysis, which is focused on the Toys Safety Directive, the RoHS Directive, and REACH, shows that the legislations differ significantly. Differences include e.g. what criteria are used for the selection of substances to be targeted for regulation, and the kind of requirements and restrictions applied to the selected substances. It is concluded that product-specific directives are important complements to REACH in order to ensure a safe use of chemicals in articles.Paper II evaluates to what extent the regulation of chemicals in articles under REACH is coherent with the rules concerning chemicals in the Sewage Sludge Directive (SSD) and the Water Framework Directive (WFD). The results show that the majority of the chemicals that are prioritized for phase-out under the WFD or for concentration restrictions in sludge and soil under the SSD are allowed to be used in articles according to REACH. In order to avoid end-of-pipe problems and to increase resource efficiency, it is argued that it is necessary to minimize the input of chemicals identified as hazardous to health or the environment into articles.Paper III aims to clarify what the substitution principle means and how it can reasonably be applied as part of chemical policies. A general definition is proposed that gives equal weight to hazard, functionality and economical considerations, while at the same time recognizing that the aim of the substitution principle is to reduce hazards to human health and the environment. This paper also summarizes major methods to promote and implement the principle, discusses legislative approaches with regard to their ability to promote substitution of hazardous chemicals, and makes proposals for an efficient implementation of the principle.
|
|
| 9. |
- Molander, Linda, 1984-
(author)
-
Chemicals in consumer products : Bridging the gap between academic research and chemicals regulation
- 2015
-
Doctoral thesis (other academic/artistic)abstract
- Exposure to chemicals emitting from consumer products, such as clothes, electronic devices, toys and kitchen-ware, has emerged as an issue of public health and environmental concern. The use of chemicals having endocrine disrupting properties in commercial products is receiving particular attention as low dose exposures of such chemicals have been associated with adverse effects in both human and wildlife populations. Current chemicals regulation has been criticized for not providing adequate protection of human health and the environment with regard to consumer products. The aim of this thesis has been to provide new insights and methods related to the risk assessment and risk management of chemicals in consumer products in order to ensure a safer and more sustainable use.The comparative analyses of different EU regulatory frameworks targeting the use of chemicals in articles identified a number of shortcomings and inconsistencies in how chemicals in articles are regulated. One main conclusion from Paper I was that product specific rules are important complements to REACH as they can more easily be tailored for certain uses and exposure scenarios. In Paper II it was investigated whether the regulation of chemicals in articles according to REACH is sufficient for meeting EU environmental goals, which include rectifying environmental problems at the source. It was concluded that the prioritization of substances to be targeted by restrictions and other requirements under REACH to a greater extent should take into account substances that have been identified as posing a risk to or via the environment.With the aim to facilitate the use of all reliable and relevant toxicity information in regulatory health risk assessment of chemicals, a method for systematic and transparent evaluation of non-standard research studies, as well as reporting guidance for such studies, were developed in Paper III. It has for example been emphasized that non-standard research studies can provide valuable information with regard to endocrine disrupting effects. Such effects are not systematically tested for in standardized studies commonly preferred in regulatory risk assessments. In Paper IV, the method for study evaluation proposed in Paper III was combined with recently developed web-based tools that aid summarizing and visualizing toxicity data extracted from several studies. The combined use was found to comprise a promising methodology for identifying reliable and sensitive information from in vivo toxicity studies of relevance to consider in the risk assessment process.The new methods and tools proposed and evaluated in this thesis will hopefully help improve the use of non-standard studies for risk assessment purposes and thereby strengthen the link between academic research and chemicals policy. In my view, this would be an important step towards improving public health protection with regard to the use of chemicals in consumer products.
|
|
| 10. |
- Molander, Linda, et al.
(author)
-
Combining web-based tools for transparent evaluation of data for risk assessment : developmental effects of bisphenol A on the mammary gland as a case study
- 2017
-
In: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 37:3, s. 319-330
-
Journal article (peer-reviewed)abstract
- Different tools have been developed that facilitate systematic and transparent evaluation and handling of toxicity data in the risk assessment process. The present paper sets out to explore the combined use of two web-based tools for study evaluation and identification of reliable data relevant to health risk assessment. For this purpose, a case study was performed using in vivo toxicity studies investigating low-dose effects of bisphenol A on mammary gland development. The reliability of the mammary gland studies was evaluated using the Science in Risk Assessment and Policy (SciRAP) criteria for toxicity studies. The Health Assessment Workspace Collaborative (HAWC) was used for characterizing and visualizing the mammary gland data in terms of type of effects investigated and reported, and the distribution of these effects within the dose interval. It was then investigated whether there was any relationship between study reliability and the type of effects reported and/or their distribution in the dose interval. The combination of the SciRAP and HAWC tools allowed for transparent evaluation and visualization of the studies investigating developmental effects of BPA on the mammary gland. The use of these tools showed that there were no apparent differences in the type of effects and their distribution in the dose interval between the five studies assessed as most reliable and the whole data set. Combining the SciRAP and HAWC tools was found to be a useful approach for evaluating in vivo toxicity studies and identifying reliable and sensitive information relevant to regulatory risk assessment of chemicals. Copyright (c) 2016 John Wiley & Sons, Ltd. The present paper explores the combined use of the Science in Risk Assessment and Policy toxicity study evaluation method and the Health Assessment Workspace Collaborative tools for identification of reliable data relevant to health risk assessment. Combining the Science in Risk Assessment and Policy and Health Assessment Workspace Collaborative tools was found to be a useful and transparent approach for evaluating in vivo toxicity studies and identifying reliable and sensitive information relevant to regulatory risk assessment of chemicals.
|
|
