scholarly journals Task-based Dermal Exposure Models for Regulatory Risk Assessment

2021 ◽  
Author(s):  
John W Green ◽  
Manousos Foudoulakis ◽  
Timothy Fredricks ◽  
Tiffany Carro ◽  
Jonathan Maul ◽  
...  

Abstract Avian reproduction studies for regulatory risk assessment are undergoing review by regulatory authorities, often leading to requests for statistical re-analysis of older studies using newer methods, sometimes with older study data that do not support these newer methods. We propose detailed statistical protocols with updated statistical methodology for use with both new and older studies and recommend improvements in experimental study design to set-up future studies for robust statistical analyses. There is increased regulatory and industry attention to the potential use of benchmark dose (BMD) methodology to derive the point of departure in avian reproduction studies, to be used as the endpoint in regulatory risk assessment. We present benefits and limitations of this BMD approach for older studies being re-evaluated and for new studies designed for with BMD analysis anticipated. Model averaging is recommended as preferable to model selection for BMD analysis. Even for a new study following the modified experimental design analyses with BMD methodology will only be possible for a restricted set of response variables. The judicious use of historical control data, identification of outlier data points, increased use of distributions more consistent with the nature of the data collected as opposed to forcing normality-based methods, and trend-based hypothesis tests are shown to be effective for many studies, but limitations on their applicability are also recognized and explained. Updated statistical methodologies are illustrated with case studies conducted under existing regulatory guidelines that have been submitted for product registrations. Through the adoption of improved avian reproduction study design elements combined with the suggested revised statistical methodologies the conduct, analyses, and utility of avian reproduction studies for avian risk assessments can be improved.


2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Roshanak Rezaei Kalantary ◽  
Neamatollah Jaafarzadeh ◽  
Mohammad Rezvani Ghalhari ◽  
Mohsen Hesami Arani

Abstract Polycyclic aromatic hydrocarbons (PAHs) are organic pollutants containing several hydrocarbon rings affecting human health according to the published monitoring data. Most of these compounds can be absorbed by the soil and sediments due to the abundance of production resources of these compounds in the soil around the cities and sediments of the Iranian coast. Cancer risk assessment (CRA) is one of the most effective methods for quantifying the potentially harmful effects of PAHs on human health. In this study, the published papers that monitored PAHs in Iran’s soil and sediments were reviewed. The extraction of different data and their equivalent factors were performed according to BaP equivalent, which is the main factor for calculating CRA of PAHs. The highest concentrations of PAHs were found in the sediments of Assaluyeh industrial zones (14,844 μg/kg), Khormousi region (1874.7 μg/kg), and Shadegan wetland (1749.5 μg/kg), respectively. Dermal exposure to sediments was 96% in adults, and 4% in children, and ingestion exposure to sediment was 99% in adults and 99.2% in children. Children dermal exposure to soil was 53%, and the accidental exposure to soil was 47%. In adults, dermal exposure to soil was 96% and the accidental exposure was 4%. The results of the present study indicated a significant, the carcinogenic risk of Polycyclic Aromatic Hydrocarbons in sediments of southern regions and soils of central regions of Iran is significant.


Data ◽  
2019 ◽  
Vol 4 (3) ◽  
pp. 98 ◽  
Author(s):  
Kathleen A Lewis ◽  
John Tzilivakis

Pollination services are vital for agriculture, food security and biodiversity. Although many insect species provide pollination services, honeybees are thought to be the major provider of this service to agriculture. However, the importance of wild bees in this respect should not be overlooked. Whilst regulatory risk assessment processes have, for a long time, included that for pollinators, using honeybees (Apis mellifera) as a protective surrogate, there are concerns that this approach may not be sufficiently adequate particularly because of global declines in pollinating insects. Consequently, risk assessments are now being expanded to include wild bee species such as bumblebees (Bombus spp.) and solitary bees (Osmia spp.). However, toxicity data for these species is scarce and are absent from the main pesticide reference resources. The aim of the study described here was to collate data relating to the acute toxicity of pesticides to wild bee species (both topical and dietary exposure) from published regulatory documents and peer reviewed literature, and to incorporate this into one of the main online resources for pesticide risk assessment data: The Pesticide Properties Database, thus ensuring that the data is maintained and continuously kept up to date. The outcome of this study is a dataset collated from 316 regulatory and peer reviewed articles that contains 178 records covering 120 different pesticides and their variants which includes 142 records for bumblebees and a further 115 records for other wild bee species.


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