Challenges of Regulation and Risk Assessment of Nanomaterials

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NANEX: Development of Exposure Scenarios for Manufactured Nanomaterials van Tongeren M. 1 , Clark K. 2 , Brouwer D. 3 , Christensen C. 4 , Micheletti C. 4 , Friedrichs S. 5 , Nowack B. 6 , Gottschalk F. 6 , Schmid K. 1 , Aitken R. 1 , Vaquero C. 7 , Gkanis V. 8 , Uzu G. 9 , Golanski L. 9 , Gerritsen R. 3 , Riediker M. 2 1IOM, Edinburgh UK; 2 IST, Lausanne, Switzerland.; 3 TNO, Zeist, The Netherlands; 4 JRC-IHCP, Ispra, Italy; 5 NIA, Brussels, Belgium; 6 EMPA, St. Gallen, Switzerland; 7 LEIA, Miñano, Spain; 8 Demokritos, Athens, Greece; 9 CEA, Grenoble, France Exposure scenarios are important tools in risk management and generally include information on substance, process and activities, presence of any risk management measures, and estimates of exposure. NANEX aimed to develop occupational and consumer exposure scenarios for carbon nanotubes, nano-TiO2 and nano-silver based on currently available information. The consumer exposure scenarios were based on models, while the occupational scenarios were developed using exposure data from literature and two measurement campaigns. In total, 57 occupational and 5 consumer exposure scenarios were developed. A number of exposure scenarios were developed in partnership with companies using or manufacturing nanomaterials. Many scenarios lacked contextual information, such as presence of risk management measures, duration of activities, operational conditions, etc. In addition, measurements were often carried out to characterize emission rather than exposure and several studies were carried out in laboratory or pilot studies, rather than real-life conditions. More detailed information on operating conditions and risk management measures were available for the development of the case study scenarios. However, the case studies did not explore all downstream use exposure scenarios. The outcome of NANEX clearly demonstrates that the currently available exposure data is of insufficient quality to develop robust and reliable exposure scenarios. To improve the quality of the exposure descriptions and potential for data sharing a minimum data set is proposed, including nano-specific and generic information. In addition, research needs were identified. In the short-term there is a need for harmonization of exposure metrics, for verification of effectiveness of risk management measures and for development of risk management strategies to be applied while waiting for development of more detailed exposure and risk assessment methodologies. Longer term research needs to focus on collection of high quality exposure and contextual data over the life cycle of nanomaterials, the advancement of our understanding of multi-metric exposure and the key exposure determinants, as well as the development, calibration and validation of nano-specific exposure estimation models. 24
Industry experience with conducting nanomaterial safety assessments Friedrichs S. 1 1 Nanotechnology Industries Association, 101 Avenue Louise, 1050 Ixelles (Brussels), Belgium Companies active in the manufacture and use of nanomaterials have conducted many nano-specific safety assessment approaches over the last few years; in some cases, companies developed the necessary approaches in house, in others, companies joined initiatives that had been developed by policy-making groups (such as the OECD WPMN) or public R&D projects (such as FP7 / FP8 projects) concerned with nano-hazard and/or –exposure assessments. Some of the most successful approaches to the safety assessment on nanomaterials were conducted on a pre-competitive basis, and involved companies of different sizes and at different stages of their establishment, representing the manufacture or use of a specific nanomaterial at different stages of its value chains. Most approaches were developed and conducted in collaboration with policy-making or –informing bodies and standardisation organisations, in order to enable the highest possible impact of the considerable financial investment that is necessary for reliable and reproducible nanomaterials safety assessments. 25
Page 1 and 2: Challenges of Regulation and Risk A
Page 3 and 4: TABLE OF CONTENTS 1. INTRODUCTION .
Page 5 and 6: 2. REGULATORY DEVELOPMENTS 2.1. Sum
Page 7 and 8: into risk assessments and risk mana
Page 9 and 10: Nanomaterials in the Regulatory Dev
Page 11 and 12: Guidance on the risk assessment of
Page 13 and 14: Current Progress of activity and ef
Page 15 and 16: of the Sponsorship programme and pr
Page 17 and 18: exposure using new metrics and to d
Page 19 and 20: and risks would increase the probab
Page 21 and 22: OECD Working Party on Manufactured
Page 23: REACH Implementation Project on Nan
Page 27 and 28: Health, Safety, and Environment: As
Page 29 and 30: 4. CHARACTERISATION AND DETECTION O
Page 31 and 32: 4.2. Abstracts 31
Page 33 and 34: Primary and secondary characterizat
Page 35 and 36: 5. EXPOSURE ASSESSMENT 5.1. Summary
Page 39 and 40: Application and adaptation of expos
Page 41 and 42: areas. The final remark was that th
Page 45 and 46: Integrating test strategy for ecoto
Page 47 and 48: Ageing and Toxicity of real NM in a
Page 49 and 50: The bioavailability and trophic tra
Page 51 and 52: 7. HUMAN TOXICITY 7.1. Summary reco
Page 55 and 56: Variation in acute toxicity for 9 e
Page 57 and 58: In conclusion, the in vitro hepatoc
Page 59 and 60: Acknowledgements The editors would
Page 61 and 62: 24 FURUNO Shoko Association (NIA) A
Page 63 and 64: 76 VOM BROCKE Jochen German Federal
Page 65 and 66: 05. NANEX: development of Exposure
Page 68 and 69: European Commission JRC 67654- Join
Page 70: The mission of the JRC is to provid

Challenges of Regulation and Risk Assessment of Nanomaterials

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