Assuring Safe Use of Engineered Nanomaterials in Industrial Settings

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1 Assuring Safe Use of Engineered Nanomaterials in Industrial Settings Governance of emerging nano-risk in the semiconductor industry, Brussels, Belgium, April 26, 2018 Kai Savolainen, Finnish Institute of Occupational Health 1

2 NANOSCALE

3 Nano-titanium dioxide particles under electron microscope Courtesy: Esa Vanhala

4 The Great Chemical Unknown a lack of resources challenges regulatory approaches [Scientific American October 28, 2010] Only a tiny fraction of chemicals around us has been tested for safety; several hundreds of thousands of chemicals synthetized by industry, and 50,000 80,000 chemicals on the global; Tens of thousands of them used by consumers and industry - Tested for hazards: ~300 Safety assessment progress with ENM? On the market for 20 years, more than 300,000 synthetized, in products on marked, 5-15 tested for safety? Challenge for all: reliable prediction of hazards & risks Tina Bahadori,

5 GROWTH OF NUMBERS OF ENM-BASED PRODUCTS Schulte et al., in press 5/4/2018 FIOH Kai Savolainen 5

6 The safety knowledge gap has increased since the entry of ENM onto the market: affordable, reliable & fast ENM safety/hazard prediction an urgent regulatory need globally (OELs) Schematic representation of emergence of nanotechnology products in comparison to generated EHS data (Linkov and Satterstrom: Nanomaterial Risk Assessment and Risk Management, 2008). 6

7 Risk assessment and risk management of traditional chemicals and ENM (Oberdörster et al Environ Health Perspect 113:823-39) has become obsolete; break throughs for hazard & risk prediction of ENM are missing so far 7

8 Occupational exposure to ENM is infrequently the highest and requires special attention Mixer/sonicator/attrition mill within ventilated enclosure (Image courtesy of Mark Methner, NIOSH) 8

9 Hazard & Risk assessment of ENM for their safe use by the industry and elsewhere Assess the lowest levels of exposures or doses that do not induce a harmful effect (in humans or the environment) Carry out in vivo and in vitro studies to identify doses/levels of exposure of harmful ENM that may cause harm in humans & to the environment with appropriate toxicity endpoints in the models Apply adequate means of approximation to identify the possible harmful effects by using NOAELs or Benchmark doses & modelling or uncertainty factors 9

10 TRANSPORTATION CONSUMER WORKER STORAGE PRODUCTION WASTE PRODUCT AIR WATER ENVIRONMENT DIET 10

11 Nanomaterial ENM & Work Environment Schulte et al. [2008] Transport Academic Research Laboratories Commercial Warehousing/Maintenance Waste Handling Start Up/Scale Up Operations Transport Warehousing/Maintenance Manufacturing/Production Warehousing/Maintenance Transport Waste Handling Incorporation in Products Maintenance of Products Manipulation of Products Application of Products - Medical Delivery Disposal / End of Life Recycling FIOH Kai Savolainen 11

12 Semiconductor industry & relevance of ENM risk assessment & management Increasing amounts of ENM are used in semiconductor industry as a part of electrical/electronic devices Some of the materials may be associated with harmful effects to human health and the environment including e.g. metallic and carbon containing nanomaterials Safety assessment of the materials per se is not different from other ENM safety assessment However, in the production processes safety issues can be adequately addressed when necessary (closed spaces, ventilation, wet processes) FIOH Presenters Name 12

13 Grouping of nanomaterials is an important means that may enable faster ENM risk assessment not yet there [Savolainen et al., 2013] 13

14 Hazard/Safety Classifier of ENM: learning genetic algorithms capable of identifying harmful features of ENM based on a huge ENM database (EU FP7 NANOSOLUTIONS Project) new hazard assessment approach OMICs In-vivo tox In-vitro tox Physchem Biocorona Data integration and Feature selection Bioidentity 14

15 Choice of environmental & mammalian test organisms E. coli (microbe) Caenorhabditis elegans Mytilus edulis Daphnia magna Earthworm (Lumbricus rubellus). Zebrafish, Trout. Rodent model (mice)

16 BEAS2B-based ENM classifier (Integrated Toxicity Endpoints) Accuracy Comparisons mirna -seq mrna -seq mrna -marray protein corona Phys -Chem Ensamble

17 In the meanwhile, workers need to be protected Focus on reducing of exposure Assure safe handling of nanomaterials at workplaces by: Appropriate and adequate ventilation Referring wet processes Effective education Health checks 17

18 Precautionary provisional Nano Reference Values (SER 2012, IFA 2014) within the EU, not implemented Description Benchmark level (8 h TWA) Examples Rigid, biopersistent nanofibres for which effects similar to those of asbestos are not excluded 0.01 fibres/cm 3 * Carbon nanotubes, carbon nanofibres, nanocellulose Biopersistent granular particles/cm 3 Ag, Au, CeO 2, CoO, Fe, Pb, SnO 2 nanomaterial; density >6000 kg/m 3 Biopersistent granular nanomaterial; density <6000 kg/m 3, size-range nm, and nanofibres for which asbestos-like effects are excluded particles/cm 3 Al 2 O 3, SiO 2, TiN, TiO 2, ZnO, nanoclays, dendrimers, polystyrene *The value is identical to the benchmark exposure limit (BEL) for fibrous nanomaterials proposed by the British Standards Institute (BSI) (BSI 2007). Values are precautionary, not health-based. 18

19 NIOSH health-based REL for nano-titanium dioxide, carbon nanotubes, not implemented NIOSH: a proposed in-house REL for titanium dioxide (tumors) of 0.3 mg/m 3 and for carbon materials (inflammation) of 1 μg/m 3 ; the values are health-based, not yet implemented A reason for the lack of material-specific OELs is the lack of resources; however, several proposals for ENM OELs are underway but need to be assessed and accepted by the regulators 19

20 Tiered scheme for nano-risk assessment (NanoStreem) FIOH Presenters Name 20

21 Control banding matrix, colors for priorization (NanoStream applications) control doable FIOH Presenters Name 21

22 Hierarchy of controls (ISO/TS :2012) at workplaces: ENM 22

23 Sustainable nano-enabled solutions for safe energy storage Lithium-ion batteries provide solutions for storing energy from transient energy types, i.e. wind & sun. The batteries also offer a means to transfer energy and to use it to warm homes, in mobiles, and cars (Tesla). Part of every day life. Now. "Li ion laptop battery" by Kristoferb. Licensed under CC BY-SA 3.0 via Wikimedia Commons - #/media/file:li_ion_laptop_battery.jpg 23

24 Nano-surfaced Church in Helsinki Downtown 24

25 Thank tyoterveyslaitos tyoterveys Tyoterveyslaitos