Dataset Information

Evaluation of Exposure Assessment Tools under REACH: Part II-Higher Tier Tools.

ABSTRACT: Stoffenmanager®v4.5 and Advanced REACH Tool (ART) v1.5, two higher tier exposure assessment tools for use under REACH, were evaluated by determining accuracy and robustness. A total of 282 exposure measurements from 51 exposure situations (ESs) were collected and categorized by exposure category. In this study, only the results of liquids with vapor pressure (VP) > 10 Pa category having a sufficient number of exposure measurements (n = 251 with 42 ESs) were utilized. In addition, the results were presented by handling/activity description and input parameters for the same exposure category. It should be noted that the performance results of Stoffenmanager and ART in this study cannot be directly compared for some ESs because ART allows a combination of up to four subtasks (and nonexposed periods) to be included, whereas the database for Stoffenmanager, separately developed under the permission of the legal owner of Stoffenmanager, permits the use of only one task to predict exposure estimates. Thus, it would be most appropriate to compare full-shift measurements against ART predictions (full shift including nonexposed periods) and task-based measurements against task-based Stoffenmanager predictions. For liquids with VP > 10 Pa category, Stoffenmanager®v4.5 appeared to be reasonably accurate and robust when predicting exposures [percentage of measurements exceeding the tool's 90th percentile estimate (%M > T) was 15%]. Areas that could potentially be improved include ESs involving the task of handling of liquids on large surfaces or large work pieces, allocation of high and medium VP inputs, and absence of local exhaust ventilation input. Although the ART's median predictions appeared to be reasonably accurate for liquids with VP > 10 Pa, the %M > T for the 90th percentile estimates was 41%, indicating that variance in exposure levels is underestimated by ART. The %M > T using the estimates of the upper value of 90% confidence interval (CI) of the 90th percentile estimate (UCI90) was considerably reduced to 18% for liquids with VP > 10 Pa. On the basis of this observation, users might be to consider using the upper limit value of 90% CI of the 90th percentile estimate for predicting reasonable worst case situations. Nevertheless, for some activities and input parameters, ART still shows areas to be improved. Hence, it is suggested that ART developers review the assumptions in relation to exposure variability within the tool, toward improving the tool performance in estimating percentile exposure levels. In addition, for both tools, only some handling/activity descriptions and input parameters were considered. Thus, further validation studies are still necessary.

SUBMITTER: Lee EG

PROVIDER: S-EPMC6939284 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluation of Exposure Assessment Tools under REACH: Part II-Higher Tier Tools.

Lee Eun Gyung EG Lamb Judith J Savic Nenad N Basinas Ioannis I Gasic Bojan B Jung Christian C Kashon Michael L ML Kim Jongwoon J Tischer Martin M van Tongeren Martie M Vernez David D Harper Martin M

Annals of work exposures and health 20190201 2

Stoffenmanager®v4.5 and Advanced REACH Tool (ART) v1.5, two higher tier exposure assessment tools for use under REACH, were evaluated by determining accuracy and robustness. A total of 282 exposure measurements from 51 exposure situations (ESs) were collected and categorized by exposure category. In this study, only the results of liquids with vapor pressure (VP) > 10 Pa category having a sufficient number of exposure measurements (n = 251 with 42 ESs) were utilized. In addition, the results wer ...[more]

PMID: 30535049

Similar Datasets

Project description:Tier 1 occupational exposure assessment tools recommended for use under the Registration, Evaluation, Authorization, and restriction of CHemicals (REACH) were evaluated using newly collected measurement data. Evaluated tools included the ECETOC TRAv2 and TRAv3, MEASEv1.02.01, and EMKG-EXPO-TOOL. Fifty-three exposure situations (ESs) based on tasks/chemicals were developed from National Institute for Occupational Safety and Health field surveys. During the field surveys, high quality contextual information required for evaluating the tools was also collected. For each ES, applicable tools were then used to generate exposure estimates using a consensus approach. Among 53 ESs, only those related to an exposure category of liquids with vapor pressure (VP) > 10 Pa had sufficient numbers of exposure measurements (42 ESs with n = 251 for TRAv2 and TRAv3 and 40 ESs with n = 243 for EMKG-EXPO-TOOL) to be considered in detail. The results for other exposure categories (aqueous solutions, liquids with VP ≤ 10 Pa, metal processing, powders, and solid objects) had insufficient measurement to allow detailed analyses (results listed in the Supplementary File). Overall, EMKG-EXPO-TOOL generated more conservative results than TRAv2 and TRAv3 for liquids with high VP. This finding is at least partly due to the fact that the EMKG-EXPO-TOOL only considers pure substances and not mixtures of chemical agents. For 34 out of 40 ESs available for chemicals with VP > 10 Pa, the liquid was a mixture rather than a pure substance. TRAv3 was less conservative than TRAv2, probably due to additional refinement of some input parameters. The percentages of exposure measurement results exceeding the corresponding tool estimates for liquids with VP > 10 Pa by process category and by input parameters were always higher for TRAv3 compared to those for TRAv2. Although the conclusions of this study are limited to liquids with VP > 10 Pa and few process categories, this study utilized the most transparent contextual information compared to previous studies, reducing uncertainty from assumptions for unknown input parameters. A further validation is recommended by collecting sufficient exposure data covering other exposure categories and all process categories under REACH.

Project description:Background and objectivesFamily caregiving interventions have been proven efficacious at reducing dementia caregiver's stress and burden, yet translation of evidence-based interventions into community-based support service programs requires modification to the original intervention protocol. In collaboration with community partners, the REACH-TX program was developed based on the REACH II (Resources for Enhancing Alzheimer's Caregiver Health) intervention. REACH-TX maintains the integrity of the multicomponent skill-based REACH II intervention but requires significantly fewer therapeutic contacts between the family caregiver and the dementia care specialist. This study presents an evaluation of REACH-TX implemented by the Alzheimer's Association North Central Texas Chapter.Research design and methodsREACH-TX was provided to 1,522 caregivers between November 2011 and December 2017. The number of therapeutic contacts scheduled for caregivers was determined by the Risk Appraisal Measure (RAM) and ranged from 1 to 23. The rate of follow-up data on outcome measures collected was 59.0% (n = 898). All five domains of the REACH II quality-of-life measure (burden, depression, social support, self-care, and problem behaviors) were assessed at baseline and at 6 months. Caregivers (n = 53) participating in the program more than once allowed us to investigate the long-term impact of the first exposure to REACH-TX and the value of repeating the program. Generalized linear models were used to assess changes in quality of life after adjusting for covariates.ResultsCaregivers who completed the program showed significant improvements from baseline to 6 months on all five domains of quality of life, as evidenced by the follow-up data. Furthermore, caregivers who enrolled a second time in REACH-TX showed significant improvement in burden and social support scores.Discussion and implicationsThis evaluation of REACH-TX suggests that REACH II evidence-based intervention can be translated into a valuable and sustainable community-based service for family caregivers. Additional translational research is needed to overcome the challenges of conducting standardized outcome assessments of caregiving services.

Project description:This study presents data on the detailed evaluation (tier 2) of a site-specific ecological risk assessment (ssERA) in a former smelter area contaminated with metals (Santo Amaro, Bahia, Brazil). Combining information from three lines of evidence (LoE), chemical (ChemLoE), ecotoxicological (EcotoxLoE) and ecological (EcoLoE), in the Triad approach, integrated risk values were calculated to rank sites and confirm the potential risk disclosed with tier 1. Risk values were calculated for the habitat and for the retention functions in each sampling point. Habitat function included the ChemLoE calculated from total metal concentrations. The EcotoxLoE was based on reproduction tests with terrestrial invertebrates (Folsomia candida, Enchytraeus crypticus, Eisenia andrei), shoot length and plant biomass (Avena sativa, Brassica rapa). For the EcoLoE, ecological parameters (microbial parameters, soil invertebrate community, litter breakdown) were used to derive risk values. Retention function included the ChemLoE, calculated from extractable metal concentrations, and the EcotoxLoE based on eluate tests with aquatic organisms (Daphnia magna reproduction and Pseudokirchneriella subcapitata growth). Results related to the habitat function indicated that the metal residues are sufficient to cause risk to biota, while the low metal levels in extracts and the general lack of toxicity in aquatic tests indicated a high soil retention capacity in most sampling points. Integrated risk of tier 2 showed the same trend of tier 1, suggesting the need to proceed with remediation actions. The high risk levels were related to direct toxicity to organisms and indirect effects, such as failure in the establishment of vegetation and the consequent loss of habitat quality for microorganisms and soil fauna. This study shed some light on the selection of tools for the tier 2 of an ssERA in tropical metal-contaminated sites, focusing on ecological receptors at risk and using available chemical methods, ecological surveys and ecotoxicity tests.

Project description:European Pesticide Registration requires a risk assessment (RA) for nontarget organisms according to EU Regulation. European Authorities have developed Guidance Documents (GDs) for RA considering exposure scenarios for the required organisms typical for terrestrial crops. The "Birds and Mammals EFSA GD" allows using multiple sources of information to extract information on species frequency needed in identifying focal species for higher-tier RA. We developed an analytical framework to calculate species frequency according to availability of species and habitat quantitative data. Since the exposure scenarios reported in the EFSA GD are inconsistent for rice, we tested the method on birds and mammals in a portion of the largest rice-cultivated area of Europe, the Italian Po floodplain. We derived three lists of focal species: (a) an expert-based list based on land-use data only, which can be useful for a preliminary exploration of potential candidate species; (b) a list derived from the interpolation of species data only, which reflects actual species frequency in rice fields; and (c) a list obtained by a species distribution model based on species monitoring and land-use data, which account for species selectivity for rice crops and are transferable to other contexts. Focal species were identified for crop-specific diet-foraging guilds, to build specific exposure scenarios to assess the risk from pesticides application in rice fields. The partial differences between our lists and those previously proposed highlight the need for identifying national lists, which can vary according to study area, biogeographic region and exposure scenarios. The application of the proposed method in European rice-producing countries should lead to crop-specific lists, which could then be integrated to obtain a flexible European list applicable to higher-tier RA. Integr Environ Assess Manag 2022;18:1020-1034. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Project description:During herbicide spray application, nontarget terrestrial plants (NTTPs) growing in the off-field area need to be protected from unacceptable effects of herbicide drift. The risk of such unintended effects is assessed in order to establish whether a particular use can be approved, possibly in combination with mitigation measures. In Europe, the risk of herbicide treatment to NTTPs is assessed on the basis of tier 2 studies done under controlled conditions in greenhouses. Following the concept of a tiered testing approach, higher tier field studies under more realistic conditions could be used to refine the risk assessment. No current guideline for conducting higher tier NTTP field studies is available. We developed an NTTP higher tier field study method done on an experimental plant community established by sowing of a seed mixture. The setup was optimized in 3 pilot field studies and subsequently used for a definitive study testing effects of the herbicide iofensulfuron-sodium. Results show that the method can be regarded as a suitable higher tier option for assessing effects of herbicides on NTTPs. Growth of species from the soil seed bank cannot be avoided and has to be carefully considered when evaluating results. Adaptations of the study design may be necessary when testing different herbicides. Community-level endpoints were at the same level as single-species endpoints. Results of the field study were compared to standard greenhouse study results for the same herbicide. No observed effect rates (NOERs) in the field were about a factor of 10 higher and show that the current tier 2 risk assessment for NTTPs can be regarded as protective in this case. Whether the present field study design and the assessed endpoints can be used in higher tier risk assessment of NTTPs depends on selection of the specific protection goal and requires further discussion. Integr Environ Assess Manag 2020;16:691-705. © 2020 Bayer AG. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Dataset Information

Evaluation of Exposure Assessment Tools under REACH: Part II-Higher Tier Tools.

Publications

Evaluation of Exposure Assessment Tools under REACH: Part II-Higher Tier Tools.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets