| 1. |
- Sandin, Per, et al.
(författare)
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Precautionary defaults - A new strategy for chemical risk management
- 2004
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Ingår i: Human and Ecological Risk Assessment. - : Informa UK Limited. - 1080-7039 .- 1549-7860. ; 10, s. 1-18
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Tidskriftsartikel (refereegranskat)abstract
- In order to give adequate support to risk managers, new risk assessment methods should be developed that are (1) scientifically sound, (2) simplified, and (3) suited for precautionary risk management. In this Perspective we propose that the notion of a precautionary default can be a useful tool in the development of such methods. A precautionary default is a cautious or pessimistic assumption that is used in the absence of adequate information and that should be replaced when such information is obtained. Furthermore, we point out some promising research areas for the development of such indicators, viz. connections between chemical characteristics such as persistence and effect parameters, monitoring of contaminants in polar regions, monitoring of contaminants in breast milk, application of results from (human) toxicology in ecotoxicology and vice versa, (eco) toxicological test systems that are sensitive to effects on reproduction, and the application of bioinformatic methods to complex data, both in genomic research and in ecotoxicology. We conclude that precautionary decision-making does not require less science, but to the contrary it requires more science and improved communication between scientists and risk managers.
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| 2. |
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| 3. |
- Bergman, Åke, et al.
(författare)
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Giftfritt – en nyttig utopi
- 2009
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Ingår i: Chemicalnet.se.
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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| 4. |
- Bergman, Åke, et al.
(författare)
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Science and policy on endocrine disrupters must not be mixed : a reply to a "common sense" intervention by toxicology journal editors
- 2013
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Ingår i: Environmental Health. - : BioMed Central (BMC). - 1476-069X. ; 12
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Tidskriftsartikel (refereegranskat)abstract
- The "common sense" intervention by toxicology journal editors regarding proposed European Union endocrine disrupter regulations ignores scientific evidence and well-established principles of chemical risk assessment. In this commentary, endocrine disrupter experts express their concerns about a recently published, and is in our considered opinion inaccurate and factually incorrect, editorial that has appeared in several journals in toxicology. Some of the shortcomings of the editorial are discussed in detail. We call for a better founded scientific debate which may help to overcome a polarisation of views detrimental to reaching a consensus about scientific foundations for endocrine disrupter regulation in the EU.
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| 5. |
- Beronius, A., et al.
(författare)
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Assessing the risks of endocrine disrupting chemicals
- 2009
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Ingår i: Endocrine disrupting chemicals in food. - : Woodhead Publishing Limited. - 9781845692186 ; , s. 356-380
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Bokkapitel (övrigt vetenskapligt/konstnärligt)abstract
- In this chapter, four European regulatory frameworks are compared concerning how they cope with identifying and risk assessing endocrine-disrupting chemicals. This comparison is performed by using four example chemicals, bisphenol A, dioxins, ethinyl estradiol and vinclozolin, representing four different regulatory categories. It is concluded that within these regulations, there are no general test requirements that specifically enable identification of endocrine disruptors, and there seem to be little conformity in the risk assessment processes even though the route of exposure and the mode of toxicity are similar. Further development of risk assessment guidance for endocrine disruptors requires continued cooperation between experimental scientists, risk assessors, regulators and industry.
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| 6. |
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| 7. |
- Beronius, Anna, et al.
(författare)
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Bridging the gap between academic research and regulatory health risk assessment of Endocrine Disrupting Chemicals
- 2014
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Ingår i: Current opinion in pharmacology (Print). - : Elsevier BV. - 1471-4892 .- 1471-4973. ; 19, s. 99-104
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Tidskriftsartikel (refereegranskat)abstract
- Regulatory risk assessment is traditionally based primarily on toxicity studies conducted according to standardized and internationally validated test guidelines. However, health risk assessment of endocrine disrupting chemicals (EDCs) is argued to rely on the efficient integration of findings from academic research. The aim of this review was to provide an overview of current developments to facilitate the use of academic research in regulatory risk assessment of chemicals and how certain aspects of study design and reporting are particularly important for the risk assessment process. By bridging the gap between academic research and regulatory health risk assessment of EDCs, scientific uncertainty in risk assessment conclusions can be reduced, allowing for better targeted policy decisions for chemical risk reduction.
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| 8. |
- Beronius, Anna, et al.
(författare)
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Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals : a proposal to improve evaluation criteria and reporting
- 2014
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Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 34:6, s. 607-617
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Tidskriftsartikel (refereegranskat)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.
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| 9. |
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| 10. |
- Beronius, Anna, et al.
(författare)
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Health risk assessment procedures for endocrine disrupting compounds within different regulatory frameworks in the European Union
- 2009
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Ingår i: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 55:2, s. 111-122
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Tidskriftsartikel (refereegranskat)abstract
- In this study we have investigated how different regulatory frameworks in Europe cope with identification and risk assessment of endocrine disrupting compounds (EDCs). Four regulatory groups were selected for the investigation: existing industrial chemicals, environmental pollutants in food, pharmaceuticals and plant protection products. The legislation and guidelines for each of these groups were scrutinized and compared in detail. In addition, one recent European risk assessment document each for three identified EDCs, i.e. bisphenol A, dioxins and vinclozolin, were reviewed and compared. We found that the requirements for toxicity testing and availability and scope of risk assessment guidelines varied between the four regulatory frameworks. Also, the general principles regarding the human relevance of the mode of action identified in animal tests differed in the different risk assessments. In conclusion, there is little conformity in the risk assessment processes between these groups of chemicals. Because of the complicated nature of endocrine disruption, test methods, principles and criteria for data interpretation traditionally used might not be directly applicable to EDCs and further development of a transparent and reliable risk assessment process for this type of substances is needed.
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| 11. |
- Beronius, A., et al.
(författare)
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Improving the transparency of data evaluation in risk assessment of endocrine disrupting compounds-Implications from the bisphenol A case study
- 2011
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Ingår i: Toxicology Letters. - : Elsevier BV. - 0378-4274 .- 1879-3169. ; 205, s. S256-S256
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- The complex biology and toxicology of endocrine disrupting compounds (EDCs) makes toxicity testing as well as evaluation of data for risk assessment difficult. Standardized test guidelines have previously been questioned as to their applicability for evaluating EDC toxicity. However, several guidelines have been updated and enhanced in an effort to better cover EDCs. Also, EDC toxicity is a very active research field and a lot of toxicological data are generated in research studies NOT conducted according to standardized guidelines. Our previous work indicates that differences in how the reliability and relevance of toxicity studies are judged may vary greatly between risk assessments of the same compound and may result in different conclusions about the size and nature of health risks. Further, the process of data evaluation is in many cases in-transparent. The purpose of this on-going study is to contribute to making health risk assessments of EDCs more transparent, systematic, and predictable. The investigation is conducted as a literature study using the EDC bisphenol A (BPA) for a case study. We scrutinize and compare the strengths and weaknesses of both guideline and non-guideline studies evaluating developmental neurotoxicity of BPA. One goal is to further assess the applicability of standardized guidelines in this case. Another aim is to propose improvements in the process of data reporting of non-guideline studies and recommend criteria for the evaluation of data in order to facilitate risk assessment of EDCs.
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| 12. |
- Beronius, Anna, et al.
(författare)
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Risk to all or none? A comparative analysis of controversies in the health risk assessment of Bisphenol A
- 2010
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Ingår i: Reproductive Toxicology. - : Elsevier BV. - 0890-6238 .- 1873-1708. ; 29:2, s. 132-146
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Tidskriftsartikel (refereegranskat)abstract
- Bisphenol A (BPA) is an endocrine disruptor for which health risk assessment has proven controversial. Conclusions regarding health risks of BPA vary between assessments from "there is no risk to any part of the population" to "there is risk to the entire population". We have carried out a literature study investigating what might be the scientific and/or policy-related reasons for these differences. Ten risk assessments for BPA were scrutinized and several factors were compared between assessments, including estimations of exposure levels, identification of critical study and NOAEL, assessment factors and significance attributed to reports of low-dose effects. Differences in conclusions were mainly influenced by the evaluation of low-dose effects and the uncertainties surrounding the significance of these data for health risk assessment. The results illustrate the impact of differences in risk assessment policy and expert judgment on the risk assessment process and highlight the importance of transparency in this process.
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| 13. |
- Beronius, Anna, et al.
(författare)
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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
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Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 38:12, s. 1460-1470
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Tidskriftsartikel (refereegranskat)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.
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| 14. |
- Beronius, Anna, et al.
(författare)
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The influence of study design and sex-differences on results from developmental neurotoxicity studies of bisphenol A, implications for toxicity testing
- 2013
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Ingår i: Toxicology. - : Elsevier BV. - 0300-483X .- 1879-3185. ; 311:1-2, s. 13-26
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Tidskriftsartikel (refereegranskat)abstract
- Developmental neurotoxicity (DNT) of bisphenol A (BPA) has been investigated in a large number of studies. However, there are discrepancies in the results reported between the studies. The aim of this study was to identify and analyze factors that may contribute to these differences and to assess whether there are sex-differences in the sensitivity of certain endpoints or tests used in DNT-studies. Forty-four DNT studies of BPA were identified from the open literature. Details about study design and results from each study, as well as the criteria for DNT testing according to the standardized OECD test guideline (TG) 426, were collected in a database. This enabled systematic and detailed comparisons between studies as well as to the criteria and recommendations stated in TG 426. Multivariate analyses were also used to investigate how different factors of the study design contributed to differences in study results. The analyses showed behavioral effects were often observed for endpoints that are not required according to OECD TG 426, such as anxiety-related, social and sexual behaviors, especially at very low doses and in female offspring. On the other hand relatively few studies observed any effects on motor activity, which is commonly used in screening for neurotoxic effects in regulatory testing. However, varied and to some extent seemingly contradictory results have been reported in these studies, especially for endpoints related to motor activity and anxiety and exploration. Many studies were also poorly reported, limiting these analyses. No strong conclusions could be drawn from the multivariate analyses. A few factors of study design, such as the size of the dose and number of dose levels used and the use of litter or individual pup as statistical unit seemed to have some influence on study results. In conclusion, this analysis suggests that DNT-studies conducted according to the standardized OECD TG 426 may overlook sensitive effects of BPA, and possibly other potential endocrine disruptors, especially in female offspring.
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| 15. |
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| 16. |
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| 17. |
- Bornehag, Carl-Gustaf, 1957-, et al.
(författare)
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A Novel Approach to Chemical Mixture Risk Assessment—Linking Data from Population-Based Epidemiology and Experimental Animal Tests
- 2019
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Ingår i: Risk Analysis. - : John Wiley & Sons. - 0272-4332 .- 1539-6924. ; 39:10, s. 2259-2271
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Tidskriftsartikel (refereegranskat)abstract
- Humans are continuously exposed to chemicals with suspected or proven endocrine disrupting chemicals (EDCs). Risk management of EDCs presents a major unmet challenge because the available data for adverse health effects are generated by examining one compound at a time, whereas real-life exposures are to mixtures of chemicals. In this work, we integrate epidemiological and experimental evidence toward a whole mixture strategy for risk assessment. To illustrate, we conduct the following four steps in a case study: (1) identification of single EDCs (“bad actors”)—measured in prenatal blood/urine in the SELMA study—that are associated with a shorter anogenital distance (AGD) in baby boys; (2) definition and construction of a “typical” mixture consisting of the “bad actors” identified in Step 1; (3) experimentally testing this mixture in an in vivo animal model to estimate a dose–response relationship and determine a point of departure (i.e., reference dose [RfD]) associated with an adverse health outcome; and (4) use a statistical measure of “sufficient similarity” to compare the experimental RfD (from Step 3) to the exposure measured in the human population and generate a “similar mixture risk indicator” (SMRI). The objective of this exercise is to generate a proof of concept for the systematic integration of epidemiological and experimental evidence with mixture risk assessment strategies. Using a whole mixture approach, we could find a higher rate of pregnant women under risk (13%) when comparing with the data from more traditional models of additivity (3%), or a compound-by-compound strategy (1.6%).
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| 18. |
- Breitholtz, M., et al.
(författare)
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Ten challenges for improved ecotoxicological testing in environmental risk assessment
- 2006
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Ingår i: Ecotoxicology and Environmental Safety. - : Elsevier BV. - 0147-6513 .- 1090-2414. ; 63:2, s. 324-335
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Forskningsöversikt (refereegranskat)abstract
- New regulations, in particular the new European chemicals legislation (REACH), will increase the demands on environmental risk assessment (ERA). The requirements on efficient ecotoxicological testing systems are summarized, and 10 major issues for the improvement of ERA practices are discussed, namely: (1) the choice of representative test species, (2) the development of test systems that are relevant for ecosystems in different parts of the world, (3) the inclusion of sensitive life stages in test systems, (4) the inclusion of endpoints on genetic variation in populations, (5) using mechanistic understanding of toxic effects to develop more informative and efficient test systems, (6) studying disruption in invertebrate endocrine mechanisms, that may differ radically from those we know from vertebrates, (7) developing standardized methodologies for testing of poorly water-soluble substances, (8) taking ethical considerations into account, in particular by reducing the use of vertebrates in ecotoxico logical tests, (9) using a systematic (statistical) approach in combination with mechanistic knowledge to combine tests efficiently into testing systems, and (10) developing ERA so that it provides the information needed for precautionary decision-making.
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| 19. |
- Breitholtz, Magnus, et al.
(författare)
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Testing and risk assessment of persistent and bioaccumulating chemical substances - Improvements within REACH?
- 2006
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Ingår i: Human and Ecological Risk Assessment. - : Informa UK Limited. - 1080-7039 .- 1549-7860. ; 12:4, s. 782-805
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Tidskriftsartikel (refereegranskat)abstract
- In the proposed new European chemicals regulations - the REACH system - the improved control of persistent and bioaccumulating substances is stated as one of the tasks being of particular importance. In this article, the reliability and validity of the scientific basis for identification of persistent ( P), bioaccumulating ( B), and toxic ( T) substances, and for assessing the risks that these substances may pose, are discussed. We have used the European Union risk assessment of pentabromodiphenyl ether, PentaBDE ( CAS 32534-81-9) as a study case in the analysis. It is concluded that for PBT substances there is room for development both with regard to test methodology and with regard to risk assessment procedures.
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| 20. |
- Bui, Thuy T., et al.
(författare)
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Applying a modified systematic review and integrated assessment framework (SYRINA) - a case study on triphenyl phosphate
- 2023
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Ingår i: Environmental Science. - 2050-7887 .- 2050-7895. ; 26:2, s. 380-399
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Tidskriftsartikel (refereegranskat)abstract
- This work presents a case study in applying a systematic review framework (SYRINA) to the identification of chemicals as endocrine disruptors. The suitability and performance of the framework is tested with regard to the widely accepted World Health Organization definition of an endocrine disruptor (ED). The endocrine disrupting potential of triphenyl phosphate (TPP), a well-studied flame retardant reported to exhibit various endocrine related effects was assessed. We followed the 7 steps of the SYRINA framework, articulating the research objective via Populations, Exposures, Comparators, Outcomes (PECO) statements, performed literature search and screening, conducted study evaluation, performed data extraction and summarized and integrated the evidence. Overall, 66 studies, consisting of in vivo, in vitro and epidemiological data, were included. We concluded that triphenyl phosphate could be identified as an ED based on metabolic disruption and reproductive function. We found that the tools used in this case study and the optimizations performed on the framework were suitable to assess properties of EDs. A number of challenges and areas for methodological development in systematic appraisal of evidence relating to endocrine disrupting potential were identified; significant time and effort were needed for the analysis of in vitro mechanistic data in this case study, thus increasing the workload and time needed to perform the systematic review process. Further research and development of this framework with regards to grey literature (non-peer-reviewed literature) search, harmonization of study evaluation methods, more consistent evidence integration approaches and a pre-defined method to assess links between adverse effect and endocrine activity are recommended. It would also be advantageous to conduct more case studies for a chemical with less data than TPP.
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| 21. |
- Caporale, N., et al.
(författare)
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From cohorts to molecules: Adverse impacts of endocrine disrupting mixtures
- 2022
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Ingår i: Science. - : American Association for the Advancement of Science (AAAS). - 0036-8075 .- 1095-9203. ; 375:6582
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Tidskriftsartikel (refereegranskat)abstract
- Convergent evidence associates exposure to endocrine disrupting chemicals (EDCs) with major human diseases, even at regulation-compliant concentrations. This might be because humans are exposed to EDC mixtures, whereas chemical regulation is based on a risk assessment of individual compounds. Here, we developed a mixture-centered risk assessment strategy that integrates epidemiological and experimental evidence. We identified that exposure to an EDC mixture in early pregnancy is associated with language delay in offspring. At human-relevant concentrations, this mixture disrupted hormone-regulated and disease-relevant regulatory networks in human brain organoids and in the model organisms Xenopus leavis and Danio rerio, as well as behavioral responses. Reinterrogating epidemiological data, we found that up to 54% of the children had prenatal exposures above experimentally derived levels of concern, reaching, for the upper decile compared with the lowest decile of exposure, a 3.3 times higher risk of language delay. © 2022 American Association for the Advancement of Science. All rights reserved.
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| 22. |
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| 23. |
- Gennings, Chris, et al.
(författare)
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Incorporating regulatory guideline values in analysis of epidemiology data
- 2018
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Ingår i: Environment International. - : Elsevier. - 0160-4120 .- 1873-6750. ; 120, s. 535-543
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Tidskriftsartikel (refereegranskat)abstract
- Fundamental to regulatory guidelines is to identify chemicals that are implicated with adverse human health effects and inform public health risk assessors about “acceptable ranges” of such environmental exposures (e.g., from consumer products and pesticides). The process is made more difficult when accounting for complex human exposures to multiple environmental chemicals. Herein we propose a new class of nonlinear statistical models for human data that incorporate and evaluate regulatory guideline values into analyses of health effects of exposure to chemical mixtures using so-called ‘desirability functions’ (DFs). The DFs are incorporated into nonlinear regression models to allow for the simultaneous estimation of points of departure for risk assessment of combinations of individual substances that are parts of chemical mixtures detected in humans. These are, in contrast to published so-called biomonitoring equivalent (BE) values and human biomonitoring (HBM) values that link regulatory guideline values from in vivo studies of single chemicals to internal concentrations monitored in humans. We illustrate the strategy through the analysis of prenatal concentrations of mixtures of 11 chemicals with suspected endocrine disrupting properties and two health effects: birth weight and language delay at 2.5 years. The strategy allows for the creation of a Mixture Desirability Function i.e., MDF, which is a uni-dimensional construct of the set of single chemical DFs; thus, it focuses the resulting inference to a single dimension for a more powerful one degree-of-freedom test of significance. Based on the application of this new method we conclude that the guideline values need to be lower than those for single chemicals when the chemicals are observed in combination to achieve a similar level of protection as was aimed for the individual chemicals. The proposed modeling may thus suggest data-driven uncertainty factors for single chemical risk assessment that takes environmental mixtures into account.
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| 24. |
- Gilek, Michael, et al.
(författare)
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Introduction
- 2010
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Ingår i: Regulating Chemical Risks. - Dordrecht : SPRINGER. ; , s. 1-5
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Bokkapitel (refereegranskat)
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| 25. |
- Hansson, Sven Ove, et al.
(författare)
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A Risk-Neutral Default for Chemical Risk Management
- 2008
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Ingår i: American Journal of Industrial Medicine. - : Wiley. - 0271-3586 .- 1097-0274. ; 51:12, s. 964-967
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Tidskriftsartikel (refereegranskat)abstract
- In many risk management decisions concerning industrial chemicals, including decisions on classification and labeling, lack of toxicity data is interpreted as (or has the same implications as) absence of toxicity In other words, if the toxicity of a chemical is unknown, it is treated as having no or low toxicit) This practice is difficult to defend from a decision-theoretical point of view. We apply standard decision theory to toxicity data and investigate an alternative approach in which substances with unknown properties are treated as if they had the average toxicity among tested substances in the group to which they belong. An index of acute toxicity is proposed and then used to define a risk-neutral hazard default that can be applied to industrial chemicals for which no specific information on acute toxicity is available. It is proposed that such a risk-neutral approach is preferable to the current practice of treating substances with unknown acute toxicity in the same manner as substances that can reasonably be assumed to have no such harmful properties. The risk-neutral approach could be generalized to other toxicological endpoints. Am. J. Ind. Med. 51:964-967, 2008.
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| 26. |
- Hansson, Sven Ove, et al.
(författare)
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A science-based strategy for chemicals control
- 2004
-
Ingår i: Industry and Environment. - 0378-9993. ; 27:2-3, s. 12-18
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Tidskriftsartikel (refereegranskat)abstract
- A number of suggestions are made in this article for amending the data requirements of the proposed European chemicals control system, REACH. These data requirements are shown to be insufficient for applying current criteria to classify substances according to their adverse effects. Use of production volume as a priority-setting criterion for data acquisition is questioned. Three alternative priority-setting mechanisms are proposed: chemical properties of the substance; results from lower tier testing; and incentives for voluntary testing. A new classification category ("insufficiently investigated") is also proposed. Substances in this category would be identified with a warning label.
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| 27. |
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| 28. |
- Hansson, Sven Ove, et al.
(författare)
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Evaluating the risk decision process
- 2006
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Ingår i: Toxicology. - : Elsevier BV. - 0300-483X .- 1879-3185. ; 218:03-feb, s. 100-111
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Tidskriftsartikel (refereegranskat)abstract
- In order to ensure that risk assessment and risk management serve their purposes efficiently, it is essential to systematically evaluate actual practices. In this overview, it is proposed that such evaluation studies constitute an important field Of Study that should be recognized as a Subdiscipline of regulatory toxicology with its own research issues and its own methodologies. Previous Such evaluation studies are summarized. Methods are described that can be used for comparing different risk assessments of one of the same substance, for checking the consistency of harmonized classifications with the available data, for assessing the actual margin of safety (i.e. size Of Uncertainty factors) in exposure limits, and for comparing different lists of exposure limits. In conclusion, some important problem areas for future evaluation studies are pointed out.
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| 29. |
- Hansson, Sven Ove, et al.
(författare)
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Improving the incentives for toxicity testing
- 2003
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Ingår i: Journal of Risk Research. - : Informa UK Limited. - 1366-9877 .- 1466-4461. ; 6:1, s. 3-21
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Tidskriftsartikel (refereegranskat)abstract
- The legal systems for the classification and labelling of chemical substances have an incentives structure that discourages rather than encourages companies to test their products. This is shown in a logical analysis of the European classification system and also in an analysis of recent changes in the classification of individual substances. Finally two methods to improve the incentives structure are proposed and discussed: the introduction of negative clauses that allow new information to lead to less strict classifications, and a new danger-class and a symbol (a question mark) that indicates serious lack of data.
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| 30. |
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| 31. |
- Hansson, Sven Ove, et al.
(författare)
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Priority-Setting in the REACH System
- 2006
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Ingår i: Toxicological Sciences. - : Oxford University Press (OUP). - 1096-6080 .- 1096-0929. ; 90:2, s. 304-308
-
Tidskriftsartikel (refereegranskat)abstract
- Due to the large number of chemicals for which toxicological and ecotoxicological information is lacking, priority setting for data acquisition is a major concern in chemicals regulation. In the current European system, two administrative priority-setting criteria are used, namely novelty (i.e., time of market introduction) and production volume. In the proposed Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) system, the novelty criterion is no longer used, and production volume will be the main priority-setting criterion for testing requirements, supplemented in some cases with hazard indications obtained from QSAR modelling. This system for priority setting has severe weaknesses. In this paper we propose that a multicriteria system should be developed that includes at least three additional criteria: chemical properties, results from initial testing in a tiered system, and voluntary testing for which efficient incentives can be created. Toxicological and decision-theoretical research is needed to design testing systems with validated priority-setting mechanisms.
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| 32. |
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| 33. |
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| 34. |
- Hansson, Sven Ove, et al.
(författare)
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The substitution principle
- 2011
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Ingår i: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 59:3, s. 454-460
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Tidskriftsartikel (refereegranskat)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.
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| 35. |
- Hansson, Sven Ove, et al.
(författare)
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Towards, a theory of tiered testing
- 2007
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Ingår i: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 48:1, s. 35-44
-
Tidskriftsartikel (refereegranskat)abstract
- Tiered testing is an essential part of any resource-efficient strategy for the toxicity testing of a large number of chemicals, which is required for instance in the risk management of general (industrial) chemicals, In spite of this, no general theory seems to be available for the combination of single tests into efficient tiered testing systems. A first outline of such a theory is developed. It is argued that chemical, toxicological, and decision-theoretical knowledge should be combined in the construction of such a theory. A decision-theoretical approach for the optimization of test systems is introduced. It is based on expected utility maximization with simplified assumptions covering factual and value-related information that is usually missing in the development of test systems.
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| 36. |
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| 37. |
- Ingre-Khans, E., et al.
(författare)
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Chemical risks and consumer products : The toxicity of shoe soles
- 2010
-
Ingår i: Ecotoxicology and Environmental Safety. - : Elsevier BV. - 0147-6513 .- 1090-2414. ; 73:7, s. 1633-1640
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Tidskriftsartikel (refereegranskat)abstract
- The European chemicals legislation, REACH, aims to ensure a high level of protection of human health and the environment. However, chemicals included in consumer products are covered only to a very limited extent even though they constitute the main source of chemical emissions. Shoes are large volume products and the overall aim of the present study was to study the ecotoxicological effects of three types of shoe soles and relate these effects to chemical emissions to the aquatic environment. The shoe soles were abraded and leached in water for 29 days and the alga Ceramium tenuicorne and the crustacean Nitocra spinipes were exposed to different concentrations of the leachate. Chemical analyses were performed to determine the chemical contents of the leachate. The main conclusions are that the shoe soles contain substances that are toxic to both test organisms, and that the toxicity is mainly explained by the presence of zinc. The estimated concentration of zinc from shoe soles in storm water runoff is low, but it still contributes to the overall load of chemicals and metals in the environment. The outlined test procedures may, in our view, provide a useful screening tool for assessing the risk that chemicals in consumer articles pose to the environment.
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| 38. |
- Ingre-Khans, Ellen, et al.
(författare)
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Improving structure and transparency in reliability evaluations of data under REACH : suggestions for a systematic method
- 2020
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Ingår i: Human and Ecological Risk Assessment. - : Informa UK Limited. - 1080-7039 .- 1549-7860. ; 26:1, s. 212-241
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Tidskriftsartikel (refereegranskat)abstract
- The goal of identifying hazardous chemicals registered under the Registration, Evaluation, Authorization and restriction of CHemicals (REACH) Regulation and taking appropriate risk management measures relies on robust data registrations. However, the current procedures for European chemical manufacturers and importers to evaluate data under REACH neither support systematic evaluations of data nor transparently communicate these assessments. The aim of this study was to explore how using a data evaluation method with predefined criteria for reliability and establishing principles for assigning reliability categories could contribute to more structured and transparent evaluations under REACH. In total, 20 peer-reviewed studies for 15 substances registered under REACH were selected for an in-depth evaluation of reliability with the SciRAP tool. The results show that using a method for study evaluation, with clear criteria for assessing reliability and assigning studies to reliability categories, contributes to more structured and transparent reliability evaluations. Consequently, it is recommended to implement a method for evaluating data under REACH with predefined criteria and fields for documenting and justifying the assessments to increase consistency of data evaluations and transparency.
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| 39. |
- Ingre-Khans, Ellen, et al.
(författare)
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Reliability and relevance evaluations of REACH data
- 2019
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Ingår i: Toxicology Research. - 2045-452X .- 2045-4538. ; 8:1, s. 46-56
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Tidskriftsartikel (refereegranskat)abstract
- Regulatory authorities rely on hazard and risk assessments performed under REACH for identifying chemicals of concern and to take action. Therefore, these assessments must be systematic and transparent. This study investigates how registrants evaluate and report data evaluations under REACH and the procedures established by the European Chemicals Agency (ECHA) to support these data evaluations. Data on the endpoint repeated dose toxicity were retrieved from the REACH registration database for 60 substances. An analysis of these data shows that the system for registrants to evaluate data and report these evaluations is neither systematic nor transparent. First, the current framework focuses on reliability, but overlooks the equally important aspect of relevance, as well as how reliability and relevance are combined for determining the adequacy of individual studies. Reliability and relevance aspects are also confused in the ECHA guidance for read-across. Second, justifications for reliability evaluations were mainly based on studies complying with GLP and test guidelines, following the Klimisch method. This may result in GLP and guideline studies being considered reliable by default and discounting non-GLP and non-test guideline data. Third, the reported rationales for reliability were frequently vague, confusing and lacking information necessary for transparency. Fourth, insufficient documentation of a study was sometimes used as a reason for judging data unreliable. Poor reporting merely affects the possibility to evaluate reliability and should be distinguished from methodological deficiencies. Consequently, ECHA is urged to improve the procedures and guidance for registrants to evaluate data under REACH to achieve systematic and transparent risk assessments.
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| 40. |
- Ingre-Khans, Ellen, et al.
(författare)
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Toxicity studies used in registration, evaluation, authorisation and restriction of chemicals (REACH) : How accurately are they reported?
- 2019
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Ingår i: Integrated Environmental Assessment and Management. - : Wiley. - 1551-3777 .- 1551-3793. ; 15:3, s. 458-469
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Tidskriftsartikel (refereegranskat)abstract
- Toxicity studies on chemicals registered under the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation are provided as summaries instead of as a full study report. Because the registration data are used by regulatory agencies to identify chemicals of concern, the study summaries must accurately reflect the information in studies. A “study summary” should include sufficient information on the objectives, methods, results, and conclusions in the full study report in order for the relevance of the study to be determined. Sometimes a “robust study summary” is required, which should contain more detailed information to enable an independent assessment of the study. The aim of the present investigation is to examine how well published toxicity papers were reflected in study summaries submitted by registrants under REACH. Summaries of 20 published studies (peer‐reviewed studies, including 1 abstract) were examined and broad categories of various types of observed differences were derived. The extent to which information in the published studies was reported, as well as how accurately the information was reflected, varied. How accurately the information was reflected also varied. Differences between the published studies and the summaries included simple typing errors, unclear and incomplete reporting, as well as the omission of information on, for example, study design, results, or interpretation of the results, which in some cases could be considered relevant for the risk assessment. This raises concerns regarding the accuracy of study summaries and their use for decision making. Moreover, the possibility for third parties to independently assess and scrutinize the summaries is limited. Considering that we rely on REACH registration data for chemical safety, all data used for risk assessment should be accessible for thorough examination and fully independent assessment.
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| 41. |
- Ingre-Khans, Ellen, et al.
(författare)
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Transparency of chemical risk assessment data under REACH
- 2016
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Ingår i: Environmental Science: Pocesses & Impacts. - : Royal Society of Chemistry (RSC). - 2050-7887 .- 2050-7895. ; 18:12, s. 1508-1518
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Tidskriftsartikel (refereegranskat)abstract
- The REACH regulation requires EU manufacturers and importers of substances to register information on the hazard and risk of their substances with the European Chemicals Agency (ECHA). Risk management of the substances is based on the provided information. It is known that conclusions on hazard and risk are influenced by expert judgements as well as potential conflict of interests. Thus, it is important that hazard and risk assessments are transparent and can be evaluated by a third party. The aim of this study is to scrutinize the transparency, i.e. the accessibility and comprehensibility, of information on substances registered under REACH. Data on repeated dose toxicity and hazard assessment conclusions were extracted for 60 substances from the REACH registration database available on the ECHA website. The data were compiled in a database for systematically evaluating the transparency of information related to the conclusions on hazard or risk. In addition, chemical safety reports (CSR) were requested from ECHA for five substances. The transparency of information on the hazard and risk of substances was found to be limited for several reasons. First, certain information was removed due to confidentiality and certain fields were not published because they could contain confidential information although the information had not been claimed confidential. Also, the extent to which registrants reported information varied, and the presentation of some data and certain terminology required further clarification. In addition, the data source for the majority of the key and supporting studies could not be identified due to confidentiality. Since registrants are only required to summarise studies, it cannot be verified whether all relevant information from non-public industry reports have been reported. Lastly, certain information related to the hazard and risk assessment were only reported in the CSR which is only available upon request; a time-consuming and work-intensive process. As information on registered chemicals is currently provided to the public, it is difficult to follow steps that are undertaken in the hazard and risk assessment. This limits the possibility for a third party to evaluate the assessment.
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| 42. |
- Ingre-Khans, Ellen, 1983-
(författare)
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Transparency within REACH? : Regulatory risk assessment of industrial chemicals
- 2018
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Chemicals provide us with many benefits but can also have adverse effects on human health and the environment. Concerns that previous European legislations were not providing adequate protection from chemical risks resulted in a new chemicals legislation – REACH – in 2007. According to REACH, the chemical industry must ensure that risks from chemicals they produce or import at or above one tonne per year can be adequately controlled. Data on the chemicals’ properties and uses, hazards and risks as well as instructions for safely handling the chemicals, must be provided by industry to the European Chemicals Agency (ECHA) before the chemicals are allowed on the European market. The information is used by ECHA and the competent authorities of the Member States to identify chemicals of concern that warrant regulation. Thus, the registered data need to be reliable and relevant as well as transparently reported to ensure that chemicals of concern can be identified. The aim of this thesis was to provide insights into the risk assessments carried out by industry under REACH to contribute to a safer use of chemicals.The results in this thesis show that information that is used for concluding on hazards and risks of chemicals as well as industry’s conclusions are reported in a semi-transparent manner and therefore difficult for third parties to fully scrutinise and evaluate (paper I). This was in part due to the protection of confidential information as laid down by law but also related to ECHA’s procedures for making information available to the public as well as industry’s reporting. Furthermore, industry is only required under REACH to summarise (eco)toxicity studies that are gathered for the risk assessment. Consequently, data based on industry studies that are not publicly available cannot be scrutinised and independently assessed by third parties. Thus, the system relies on studies being accurately summarised by the registrant although this was not always seen to be the case (paper IV). Furthermore, the current framework for industry to evaluate (eco)toxicity studies and report data evaluations under REACH was found to be neither systematic nor transparent (paper II). Studies may not be evaluated based on their inherent scientific quality when the Klimisch method for evaluating data is used, which is the recommended data evaluation method under REACH. Using the Klimisch method may also result in giving less weight to non-standard studies, such as many academic research studies, than studies performed according to standardised test guidelines, although non-standard studies could contribute with important information to the risk assessment. The structure and transparency of data evaluations could be improved by using a framework that has clear criteria and guidance as well as a structured format for reporting data evaluations (paper III). This would support more harmonised and transparent data evaluations and encourage studies to be evaluated according to their inherent scientific quality rather than mere compliance with standardised test guidelines.The overall objective of this thesis is to contribute to the development of systematic and transparent risk assessments under REACH, which is critical for using chemicals safely.
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| 43. |
- Johannesson, Mikael, et al.
(författare)
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Risk Management - the Swedish way(s)
- 1999
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Ingår i: Journal of Environmental Management. ; 57, s. 267-281
-
Tidskriftsartikel (refereegranskat)
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| 44. |
- Kättström, Diana, 1983-, et al.
(författare)
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An analysis of the impact of the new CLP hazard classes on EU chemicals legislation
-
Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- The European Union (EU) recently introduced four [MÅ1] new hazard classes to the Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008. The classes are endocrine disruption for human health (ED HH) and the environment (ED ENV), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), and persistent, mobile and toxic (PMT) or very persistent and very mobile (vPvM). This action was a direct consequence of the EU's Chemicals Strategy for Sustainability, which aims at strengthening the protection of human health and the environment, as well as reinforcing the CLP Regulation as the central piece of the chemicals legislation. This study examined the regulatory obligations triggered by these new hazard classes, as well as the existing obligations for endocrine disrupters and PBT/vPvB substances identified in other EU regulations. In addition, we compared the CLP criteria for endocrine disruption and PBT/vPvB to criteria existing in other EU regulations and investigated how these criteria are used in the EU chemicals legislation. The European Union (EU) recently introduced four new hazard classes to the Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008. The classes are endocrine disruption for human health (ED HH) and the environment (ED ENV), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), and persistent, mobile and toxic (PMT) or very persistent and very mobile (vPvM). This action was a direct consequence of the EU's Chemicals Strategy for Sustainability, which aims at strengthening the protection of human health and the environment, as well as reinforcing the CLP Regulation as the central piece of the chemicals legislation. This study examined the regulatory obligations triggered by these new hazard classes, as well as the existing obligations for endocrine disrupters and PBT/vPvB substances identified in other EU regulations. In addition, we compared the CLP criteria for endocrine disruption and PBT/vPvB to criteria existing in other EU regulations and investigated how these criteria are used in the EU chemicals legislation. We found that the implementation of the new hazard classes under the CLP Regulation into existing EU chemicals legislation will require the revision of all regulations that rely on the CLP hazard criteria for risk management. Without revision, the immediate impact of the new hazard classes will only extend to the six regulations and the regulatory obligations they contain, all of which apply to all hazardous substances under the CLP Regulation. Meanwhile, substances with endocrine disrupting and PBT/vPvB properties are already being identified and regulated using criteria from regulations other than the CLP. When comparing the criteria for identification of endocrine disrupters and PBT/vPvB substances across the chemicals legislation, we found that the criteria differed between regulations. The findings aim to support the efficient implementation of the new CLP hazard classes and harmonization of criteria across regulations, in line with the Chemicals Strategy for Sustainability.
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| 45. |
- Kättström, Diana, 1983-, et al.
(författare)
-
Fulfilling the criteria for CLP classification: the implications for substances under the EU chemicals legislation
-
Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- The implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) through Regulation (EC) 1272/2008 (CLP) is central to chemical regulation in the European Union (EU). The CLP mandates manufacturers and importers to classify substances and mixtures according to hazard criteria, with notifications submitted to the European Chemicals Agency (ECHA). Substances meeting hazard criteria must be appropriately labelled and packaged to communicate hazards effectively. The CLP establishes hazard classification criteria but does not independently restrict the use of hazardous chemicals. Instead, it serves as a basis for regulatory obligations in other specific regulations. This study investigates the regulatory implications of meeting hazard criteria under the CLP across EU regulations and directives listed in EUCLEF. Results reveal that fulfilling criteria for human health hazard classes triggers regulatory obligations in the highest number of regulations/directives, with carcinogenicity, mutagenicity, and reproductive toxicity (CMR) leading to obligations in 19 of 20 pieces of legislation linked to the CLP. Conversely, physical, environmental, and ozone layer hazards are associated with fewer regulations and directives, resulting in fewer prohibitions.The study underscores the pivotal role of the CLP in EU chemical legislation and the need for coherence and consistency across regulations. While regulatory obligations are primarily aimed at substances meeting hazard criteria, issues with self-classification variability and limitations in harmonized classification processes were observed. Moreover, the complexity of the regulatory structure poses challenges for stakeholders and policymakers, including inconsistencies, compliance difficulties, and the need for frequent revisions. Addressing these challenges is critical for enhancing regulatory effectiveness and ensuring a more coherent and harmonized approach to chemical management in the EU.
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| 46. |
- Kättström, Diana, et al.
(författare)
-
Out of REACH : environmental hazards of cosmetic preservatives
- 2024
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Ingår i: Human and Ecological Risk Assessment. - 1080-7039 .- 1549-7860.
-
Tidskriftsartikel (refereegranskat)abstract
- The EU Cosmetic Products Regulation requires neither environmental data nor environmental risk assessment for individual ingredients or finished cosmetic products. Instead, it relies on REACH to address environmental risks linked to cosmetic ingredients, including preservatives. We investigated how the environmental risks of cosmetic preservatives are managed by REACH. We identified preservatives of environmental concern and examined if any of these had been selected for Substance Evaluation, proposed for or identified as an SVHC, required authorization or were proposed for, or subject to, restriction under REACH. More than half of the preservatives approved under the Cosmetic Product Regulation, 70 of 137, were identified as being of environmental concern according to the criteria set in this study. Some of the approved preservatives were no longer produced or used in the EU due to their hazardous properties. However, they remained approved and may still enter the EU via the imported products. Our results also indicate that the environmental aspects of cosmetic ingredients, including preservatives, are not efficiently managed by REACH. Besides the known issues in REACH, we identified additional areas in the interface between REACH, CLP and the Cosmetic Products Regulation that call for improvement. Here, we provide practical suggestions in line with the Chemicals Strategy for Sustainability. If implemented, these measures would strengthen the protection of the environment from hazardous cosmetic ingredients.
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| 47. |
- Kättström, Diana, et al.
(författare)
-
Stricter regulation applies to antimicrobial substances when used as biocides compared to cosmetics under current EU legislation
- 2022
-
Ingår i: Emerging Contaminants. - : Elsevier BV. - 2405-6650 .- 2405-6642. ; 8, s. 229-242
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Tidskriftsartikel (refereegranskat)abstract
- Antimicrobial substances are substances that have the ability to kill or slow down the growth of microorganisms such as bacteria, algae and fungi. Exposure of microorganisms to low concentrations of antimicrobial substances may lead to the development of antimicrobial resistance. To protect human health and the environment and to limit resistance, the risks for the release of these substances into the environment should be minimized from all sources. Under the current EU legal framework, some specific uses of antimicrobial substances are strictly regulated whereas others are not. When antimicrobial substances are used as active substances in biocidal products, such as disinfectants, they are regulated by Biocidal Products Regulation. When the same substances are used as preservatives in cosmetic products they fall under Cosmetic Products Regulation. In this paper, we investigated how the regulation of antimicrobial substances differ when used in biocidal products compared to cosmetic products. This was achieved by performing a systematic comparison using document analysis with focus on aims, scope, information requirements, and risk assessment procedures for biocidal active substances and cosmetic preservatives. One of the main differences identified is that no environmental data or environmental risk assessment are required for approval of cosmetic preservatives. In contrast, environmental data and risk assessment for both the active substances and one representative product would be required for the approval of the same substance if used as a biocidal active substance. This means first that a substance not approved for use in biocidal products due to its hazardous environmental properties can still be approved as a cosmetic preservative. And second, the environmental release of antimicrobial substances from cosmetic products remains unassessed and uncontrolled, despite the obvious risks of cosmetic ingredients being emitted into the environment via wastewater. From this, we recommend that an environmental risk assessment is added to the requirements for market approval of cosmetic preservatives to achieve the aim of a high level of protection for the environment as set by several EU regulations. This would be in line with the “one substance – one assessment” approach proposed by the European Commission. While the details of “one substance – one assessment” approach are not decided, it is believed to contribute to more coordinated and transparent chemical safety assessments and enhance interlinking between the regulations.
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| 48. |
- Levin, Rikard, et al.
(författare)
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Indicators of uncertainty in chemical risk assessments
- 2004
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Ingår i: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 39:1, s. 33-43
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Tidskriftsartikel (refereegranskat)abstract
- For most of the chemical substances that are subject to regulatory and industrial decision making, important toxicological data are missing. The available dataset is often difficult to interpret, and the differences between alternative, scientifically reasonable interpretations may have major impact on decision making. Since such uncertainties are an important factor in decision making it is essential that they be reported in a transparent and understandable way. In order to clarify how toxicologists report uncertainties, 30 risk assessments for one and the same substance (trichloroethylene) from the years 1973-2001 were searched for phrases indicating uncertainty. These phrases can be divided between four categories: contentual, epistemic, conditionalising, and inferential uncertainty indicators. A typology of uncertainty indicators, based on these categories, is proposed. It is concluded that the use of uncertainty indicators in these texts is not transparent and that the development of standardised uncertainty indicators should significantly improve communications both within the scientific community and between scientists and policymakers.
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| 49. |
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| 50. |
- Lindblom, Lars, 1971-, et al.
(författare)
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How agencies inspect : a comparative study of inspection policies in eight Swedish government agencies
- 2003
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- BackgroundThe regulatory approach used by SKI has an impact on the licensee and, therefore, indirectly on the safety of the nuclear facilities. The regulatory policy and its implementation also influences the way SKI is working and the competency needed by the regulator as well as by the industry. One of SKI´s tasks is to be able adjust the regulatory approach to current and future needs.Little research is available on the use of regulatory strategies, methods and activities used by regulatory agencies in their work (to assure safety), as well as their impacts. To address this gap in knowledge, SKI has contracted two separate research projects. This project, where the focus is on comparing inspection policies in Swedish government agencies, and another one where regulatory strategies across selected countries, are studied and compared.SKI´s purpose and goalsThe goal of this research project is to gain knowledge about selected Swedish agencies and their inspection policies. All the selected agencies are working with issues regarding health, environmental protection or safety. A number of persons at each agency have been interviewed about the regulatory work at their organizations. A questionnaire was developed as a first part of the project, and it was used during the interviews.In addition to provide insights as a basis for improvement within SKI, the purpose has been to promote exchange of experience between agencies with similar tasks. By this study SKI also wanted to contribute to the development of competency in this field of research.ResultsA lot of information has been gathered and analyzed during the project. The focus of the research is on comparing agencies and their practices. The report includes an analysis regarding similarities and differences in a number of areas across the agencies. The report also provides information and evidence on the problems related to comparison between agencies, partly due to the difference in the use of definitions. The recommendations resulting from this study focus on improving cooperation among Swedish agencies and on improving inspection methodologies, areas where further analysis is suggested. The conclusions and recommendations in the report belong to the persons participating in this work, and are not necessarily the same as the once drawn by SKI.
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