Periodic Reporting for period 2 - POLYRISK (POLYRISK - Understanding human exposure and health hazard of micro- and nanoplastic contaminants in our environment)
Berichtszeitraum: 2022-10-01 bis 2024-03-31
POLYRISK addresses human health effects of Micro- and Nano-Plastics (MNP), being a potential economic and social concern. Governments are under public pressure to regulate Micro- and Nano-Plastics (MNP); at the same time industry cautions that excessive regulation would harm European prosperity. Policy makers facing this challenge currently lack the scientific evidence needed to inform decision-making. Science has so far produced neither sufficient regulatory-relevant data, nor mechanistic models, nor human population-level risk management tools for MNP.
POLYRISK aims to lay the foundation for a novel approach to Human Risk Assessment (HRA) for MNP, taking into account MNP’s complex composition. We combine methodologies for exposure and hazard assessment into an iterative, tiered approach according to principles of the Integrated Approach to Testing and Assessment (IATA) as recommended by OECD, ECHA, EFSA and the JRC. Within the IATA principles we have chosen priorities to rapidly deliver regulatory relevant new data for MNP risks of primary concern. To accomplish our aim POLYRISK is working on the following objectives:
Objective 1. Develop and apply innovative sampling, sample preparation and analytics to assess internal (human matrices) and external (abiotic) exposure to MNP
Objective 2. Develop and apply a human-based in vitro toolbox for testing epithelial transfer and immunotoxicity of MNP
Objective 3. Assess exposure and biological effects of MNP in real-life scenarios
Objective 4. Establish a risk assessment strategy and execute HRA for MNP
Objective 5. To manage data for current use in developing MNP risk assessment strategy and for future in silico predictions
Objective 6. Exchange and communicate information knowledge to our stakeholders
POLYRISK aims to lay the foundation for a novel approach to Human Risk Assessment (HRA) for MNP, taking into account MNP’s complex composition. We combine methodologies for exposure and hazard assessment into an iterative, tiered approach according to principles of the Integrated Approach to Testing and Assessment (IATA) as recommended by OECD, ECHA, EFSA and the JRC. Within the IATA principles we have chosen priorities to rapidly deliver regulatory relevant new data for MNP risks of primary concern. To accomplish our aim POLYRISK is working on the following objectives:
Objective 1. Develop and apply innovative sampling, sample preparation and analytics to assess internal (human matrices) and external (abiotic) exposure to MNP
Objective 2. Develop and apply a human-based in vitro toolbox for testing epithelial transfer and immunotoxicity of MNP
Objective 3. Assess exposure and biological effects of MNP in real-life scenarios
Objective 4. Establish a risk assessment strategy and execute HRA for MNP
Objective 5. To manage data for current use in developing MNP risk assessment strategy and for future in silico predictions
Objective 6. Exchange and communicate information knowledge to our stakeholders
In the second period, POLYRISK continued working on planned activities:
WP1 has worked extensively on examining the samples of WP3, including air, blood and water samples. Methods that were earlier developed had to be adjusted for the use in POLYRISK and are currently used to test samples for the presence of MNP.
In WP 2 we have confirmed and extended research with the MNP produced by WP1 (nano-PE, nano-PP and PET) and with several other MNP obtained via CUSP partners (PET from Plastic heal and from Imptox) and via the Dutch Research project Momentum (PVC, PP, PA, of various size ranges). Research methods included various immune cells.
During the second reporting period, WP3 completed 3 of the 5 human scenario studies, i.e. the traffic study, the football study and the textile studies. Air samples were collected using different filters and analytical work to measure total mass, total rubber and total plastics on the filter is ongoing and some preliminary data was received from WP1 partners. Biological samples (blood, PBMCs, plasma, saliva and urine) were collected from the study participants and analysis of a selection of the samples is ongoing to measure rubber and plastics and immunological parameters in blood and saliva. Some preliminary data is available, but data will be reported in upcoming D3.1.
In WP4 a risk assessment framework (RAF) has been constructed using modern approaches in chemical risk assessment and implementing current state-of-the-art from scientific publications, relevant guidance documents and (draft) assessment frameworks that have been established in the field of particle and fibre toxicology.
The activities of WP5 have resulted in user-friendly usage of data templates to facilitate incorporation of MNP hazard and physicochemical data into the eNanoMapper platform. POLYRISK's responsibility for the CUSP WG on data has led to acceptance of the data templates by other CUSP-projects and by the Momentum-consortium. Standard operating procedures (SOPs) that match with the data will be submitted to the platform.
WP1 has worked extensively on examining the samples of WP3, including air, blood and water samples. Methods that were earlier developed had to be adjusted for the use in POLYRISK and are currently used to test samples for the presence of MNP.
In WP 2 we have confirmed and extended research with the MNP produced by WP1 (nano-PE, nano-PP and PET) and with several other MNP obtained via CUSP partners (PET from Plastic heal and from Imptox) and via the Dutch Research project Momentum (PVC, PP, PA, of various size ranges). Research methods included various immune cells.
During the second reporting period, WP3 completed 3 of the 5 human scenario studies, i.e. the traffic study, the football study and the textile studies. Air samples were collected using different filters and analytical work to measure total mass, total rubber and total plastics on the filter is ongoing and some preliminary data was received from WP1 partners. Biological samples (blood, PBMCs, plasma, saliva and urine) were collected from the study participants and analysis of a selection of the samples is ongoing to measure rubber and plastics and immunological parameters in blood and saliva. Some preliminary data is available, but data will be reported in upcoming D3.1.
In WP4 a risk assessment framework (RAF) has been constructed using modern approaches in chemical risk assessment and implementing current state-of-the-art from scientific publications, relevant guidance documents and (draft) assessment frameworks that have been established in the field of particle and fibre toxicology.
The activities of WP5 have resulted in user-friendly usage of data templates to facilitate incorporation of MNP hazard and physicochemical data into the eNanoMapper platform. POLYRISK's responsibility for the CUSP WG on data has led to acceptance of the data templates by other CUSP-projects and by the Momentum-consortium. Standard operating procedures (SOPs) that match with the data will be submitted to the platform.
Exposure and hazard data are instrumental to assess (human) health risks. The current state of the art is limited with regard to key technologies to assess exposure levels and hazards of MNP. POLYRISK will develop and provide standard operating procedures (SOPs) to perform physico-chemical analyses of microplastics (above 100 nm) in airborne, blood and water samples. In particular for innovative analyses in complex matrices (e.g. blood) will have potential impact with regard to execution of future studies into health effects of MNP. A particular expertise of POLYRISK is the possibility to analyse MNP of nanosize (<50 nm, using). The technology applied (AFM-PIFM) will enable answering specific questions, but will not likely be implementable as quantitative technology.
The test strategy foreseen for hazard assessment for MNP will be a tiered one, and includes fit-for-purpose in vitro test methods, as much as possible using human cells. Such a strategy was already proposed for toxicity testing of nanoparticles, but needs adaption for the case of MNP. A similar challenge is dosimetry of particles in cellular in vitro methods. Special for MNP is the complex chemistry, which combines MNP specific chemicals and leachates with adsorbed environmental (chemical and microbial pollutants). POLYRISK aims to offer innovative exposure technologies and provide new information on effects of weathering and aging of MNP. POLYRISK will focus on immunotoxicological effects MNP, in particular those that are inflammation-related. Selection of methods used is guided by the recently defined key events of inflammation. These methods will be used to test virgin as well as laboratory aged MNP and particles collected during the scenario studies. Together with exposure and health effect findings obtained in our unique and human-relevant scenario studies, POLYRISK will potentially provide unique data allowing direct in vitro to in vivo translation of MNP’s effects.
Selection of in vitro test methods of POLYRISK are centered around key event (KE) of inflammation, that have been recently defined as hubs of many inflammatory adverse outcomes (Villeneuve et al 2018). These KE include cellular activation, release of inflammatory mediators and recruitment of leukocytes. We will use methods to assess KE-related effects but also methods to assess in vitro exposure, in particular uptake of MNP by epithelial cells and leukocytes. With these methods we have already provided new insights (van den Berg et al) and expect to deliver additional mechanistic insights. This knowledge will be of strategic importance in safety-by-design R&D of new MNP.
Need for science based input for policy making and regulation.
POLYRISK is providing a state of the art risk assessment framework, that is adjusted to logically combine existing regulatory guidances for fibres, polymer of low concern, and particles. POLYRISK will thus potentially contribute to an innovative Integrated Approach to Testing and Assessment (IATA) and a novel human risk assessment framework for MNP. Such a IARA and HRA will impact on policy making and regulation.
Society is increasingly concerned about the overwhelming plastic worldwide environmental pollution. Knowledge on potential health effects of MNP on human health is barely available and highly needed. With its unique project approach, combining high-end physico-chemical analytical technologies, with tiered in vitro approaches to test MNP’s immunotoxicity and human exposure and effect studies, POLYRISK will be able provide required information to better substantiate existing concerns.
The test strategy foreseen for hazard assessment for MNP will be a tiered one, and includes fit-for-purpose in vitro test methods, as much as possible using human cells. Such a strategy was already proposed for toxicity testing of nanoparticles, but needs adaption for the case of MNP. A similar challenge is dosimetry of particles in cellular in vitro methods. Special for MNP is the complex chemistry, which combines MNP specific chemicals and leachates with adsorbed environmental (chemical and microbial pollutants). POLYRISK aims to offer innovative exposure technologies and provide new information on effects of weathering and aging of MNP. POLYRISK will focus on immunotoxicological effects MNP, in particular those that are inflammation-related. Selection of methods used is guided by the recently defined key events of inflammation. These methods will be used to test virgin as well as laboratory aged MNP and particles collected during the scenario studies. Together with exposure and health effect findings obtained in our unique and human-relevant scenario studies, POLYRISK will potentially provide unique data allowing direct in vitro to in vivo translation of MNP’s effects.
Selection of in vitro test methods of POLYRISK are centered around key event (KE) of inflammation, that have been recently defined as hubs of many inflammatory adverse outcomes (Villeneuve et al 2018). These KE include cellular activation, release of inflammatory mediators and recruitment of leukocytes. We will use methods to assess KE-related effects but also methods to assess in vitro exposure, in particular uptake of MNP by epithelial cells and leukocytes. With these methods we have already provided new insights (van den Berg et al) and expect to deliver additional mechanistic insights. This knowledge will be of strategic importance in safety-by-design R&D of new MNP.
Need for science based input for policy making and regulation.
POLYRISK is providing a state of the art risk assessment framework, that is adjusted to logically combine existing regulatory guidances for fibres, polymer of low concern, and particles. POLYRISK will thus potentially contribute to an innovative Integrated Approach to Testing and Assessment (IATA) and a novel human risk assessment framework for MNP. Such a IARA and HRA will impact on policy making and regulation.
Society is increasingly concerned about the overwhelming plastic worldwide environmental pollution. Knowledge on potential health effects of MNP on human health is barely available and highly needed. With its unique project approach, combining high-end physico-chemical analytical technologies, with tiered in vitro approaches to test MNP’s immunotoxicity and human exposure and effect studies, POLYRISK will be able provide required information to better substantiate existing concerns.