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

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

Market of final products incorporating nanotechnology Market of final products incorporating nanotechnology: the long- term vision for (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 (Nano1 in the figure) to applications-driven fundamental and nanosystem research in (Nano2). ROCO M et al: Nanotechnology Research Directions for Societal Needs in 2020 NSF, WTEC report, September 2010

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

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

Life Cycle Impact Assessment

Range of workplaces in which exposure to ENM can take place

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

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

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

NIOSH [TiO2 as an example] Ultrafine (Nanoscale) TiO 2 Recommended Exposure Limit –0.3 mg/m 3 (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

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

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