Exposure assessment Session 1: Risk Assessment – Scientific Challenges

1. Exposure assessment Session 1: Risk Assessment – Scientific Challenges EP STOA Panel – European Commission Brussels, 21 Nov 2011 Kai Savolainen, Finnish Institute of Occupational Health

2. Essence of engineered nanomaterials (ENM) that enable nanotechnologies • Small, more reactive, unpredictable • Enabling • Very varied • Huge potential • Risk unknown or poorly known • hundreds of thousands of different ENM

3. Market of final products incorporating nanotechnology Market of final products incorporating nanotechnology: the long-term vision for 2000-2020 (solid line, see Chapter on Long View) and outcomes in 2009 (survey by Lux Research, Chapter 13). The R&D focus evolves from fundamental discoveries in 2000-2010 (Nano1 in the figure) to applications-driven fundamental and nanosystem research in 2010-2020 (Nano2). ROCO M et al: Nanotechnology Research Directions for Societal Needs in 2020 NSF, WTEC report, September 2010

4. BOTH EXPOSURE AND HAZARD ARE REQUIRED TO POSE A RISK BY ENM HAZARD X EXPOSURE = RISK

5. INJECTION DERM Altistuminen: lähteet, kohteet, & reitit UK Royal Society & Royal Academy of Engineering Report on Nanoscience & nanotechnologies (2004)

6. Life Cycle Impact Assessment

7. Range of workplaces in which exposure to ENM can take place

8. Challenge: How to use a limited amount of exposure data to develop risk management guidance? Actual ENM Studied for Exposure Universe of Potential ENM Generalizability

9. Typical for occupational exposure to ENM, most important, inhalation • Working and workplace ENM levels often correlate poorly; occupational exposure usually low, high though possible • Technology does not yet enable ENM distinction from background nanoparticles: knowledge-based OELs , other values, and their enforcement, not possible • Consumers and environmental exposure likely, now occupational exposure the main concern • How to deal with exposure regulation to ENM in the European Union? – APPROACHES NEXT

10. Proposal for Benchmark Levels (IFA) – basis on what can be measured on top of the levels of background nanoparticles (traffic) • German IFA (Insurance system's research institute at Sankt Augustin) has proposed benchmark values not to be exceeded based on ENM number concentrations • These values are not science- or health-based but policy-driven (precautionary) and based also on our current ability to separate potential exposure to ENM above the ubiquitous background nanoparticles

12. NIOSH [TiO2 as an example] Ultrafine (Nanoscale) TiO2 • Recommended Exposure Limit • 0.3 mg/m3 (TWA for up to 10 hrs/day for a working lifetime) • Estimated to reduce risk of lung cancer below 1 in 1000 • recommendation based on mathematic modeling not used in the EU

13. Take home message: How to deal with the regulation of exposure to ENM in the EU? THERE ARE TWO APPROACHES: • Benchmark or P-NRV WHICH are not health- or science- but policy-based, and pragmatic • Health-based provisional in-house occupational exposure levels (OEL; NIOSH/USA) • Measurement challenges - parameters to be used [mass, number concentrations, surface area]- need to be solved by using emerging results of EU-funded and other research • Science cannot yet give an answer how to regulate exposure to ENM - more understanding on associations between exposure and effects of ENM required; justified to use precautionary principle

14. Thank you Acknowledgements EU FP7 project NANODEVICE EU FP6 project NANOSH Nanoscience research programme FinNano (Academy of Finland) Graduate School in Environmental Health (SYTYKE)