EXPOSURE MEASUREMENT AND EXPOSURE MITIGATION: ACTIVITIES OF OECD S WORKING PARTY ON MANUFACTURED NANOMATERIALS Peter Kearns, PhD OECD, ENV/EHS BIPM, April 2015
Areas covered by the OECD Programme Testing and Assessment Regulatory Programmes and Risk Assessment Exposure Measurement and Mitigation Environmentally Sustainable Use of Nanomaterials 2
OECD COUNCIL RECOMMENDATION Endorsed by the OECD Council on 19 th September 2013, recommends that: Regulatory Frameworks are valid (might need to be adapted) Members, in the testing of manufactured nanomaterials, apply the OECD Test Guidelines, adapted as appropriate to take into account the specific properties of manufactured nanomaterials; the OECD Principles of Good Laboratory Practice; It is open to non-members. 3
Mutual Acceptance of Data (MAD) A single quality standard should be applied for testing of all chemical substances Test Guidelines Good Laboratory Practice A single quality standard for test facilities throughout OECD Mutual Acceptance of Data Legally binding on OECD Member countries Avoids duplication of testing: around Euros 150 million saved each year Reduces use of animals Reduces trade barriers
TESTING AND ASSESSMENT International effort to share the testing of an agreed set of manufactured nanomaterials selected by WPMN test selected MNs for selected endpoints (completed) evaluation of data www.oecd.org/env/nanosafety 5
Lead sponsor(s) Co-sponsor(s) Status of the Dossier Fullerenes (C60) Japan, US Completed SWCNTs Japan, US Completed MWCNTs Japan, US Korea, BIAC Completed Silver nanoparticles Korea, US Australia, Canada, Germany, Nordic Council of Ministers Completed Iron Nanoparticles China BIAC Completed Titanium dioxide Cerium oxide France, Germany US, UK/BIAC Austria, Canada, Korea, Spain, US, EC, BIAC Australia, Netherlands, Spain Zinc oxide UK/BIAC Australia, US, BIAC Silicon dioxide France, EC Belgium, Korea, BIAC Completed Completed Completed Completed Dendrimers Spain, US Completed Nanoclays BIAC pending 6
List of Endpoints Addressed by the OECD Testing Programme Nanomaterial Information/Identification (9 endpoints) substance name, chemical identity, uses, coating Physical-Chemical Properties and Material Characterization (17 endpoints) water solubility, particle size, agglomeration/aggregation Environmental Fate (15 endpoints) biodegradability, adsorption, accumulation Environmental Toxicology (6 endpoints) effects on aquatic and terrestrial organisms Mammalian Toxicology (9 endpoints) inhalative toxicity, reproductive toxicity, genotoxicity Material Safety (3 endpoints) flammability www.oecd.org/env/nanosafety 7
Test Guidelines Applicability and Sample Preparation and Dosimetry a review of 115 OECD test guidelines (TGs) Most TGs are suitable but that, in some cases, modification are needed in order to apply them to manufactured nanomaterials. Guidance on Sample Preparation and Dosimetry to assist in the safety testing of nanomaterials 8
Test Guideline assessment: Expert workshops Inhalation toxicity (December 2011) Environmental fate and eco-toxicity (January 2013) Physical-chemical properties (in collaboration with ISO TC229) (March 2013) Nano genotoxicty (18-19 November, Canada) Toxicokinetics (26-28 February, Korea) Grouping of nanomaterials (September, United States) 9
Test Guideline Development Amendments to the Inhalation Test Guidelines and Associated Guidance to Accommodate Nanomaterials (lead, the United States); Decision Tree Guidance on Aquatic (and Sediment) Toxicity Testing of Nanomaterials (leads, Canada and the United States); Guidance Document on Assessing the Apparent Accumulation Potential of Nanomaterials (leads, United Kingdom and Finland); Guidance Document for Dispersion and Dissolution of Nanomaterials in Aquatic Media Decision tree (lead, Germany); Test Guideline for Dispersability and Dispersion Behaviour of Nanomaterials in Aquatic Media (lead, Germany); Test Guideline for Dissolution of Nanomaterials in Aquatic Media (lead, United States); and Test Guideline on Nanomaterial Removal from Wastewater (lead, United States). 10
Exposure publications Preliminary Analysis of Exposure Measurement and Exposure Mitigation in Occupational Settings: Manufactured Nanomaterials (2009) Identification, Compilation and Analysis of Guidance Information for Exposure Measurement and Exposure Mitigation: Manufactured Nanomaterials (2009) Emission Assessment for Identification of Sources and Release of Airborne Manufactured Nanomaterials in the Workplace: Compilation of Existing Guidance (2009) Comparison of Guidance on Selection of Skin Protective Equipment and Respirators for Use in the Workplace: Manufactured Nanomaterials (2009) Report of an OECD Workshop on Exposure Assessment and Exposure Mitigation: Manufactured Nanomaterials (2009) Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories (2010) 11
Upcoming publications/ activities Available Methods and Models for Assessing Exposure to MNs Exposure Assessment of Nano-silver: Case Study Harmonized Tiered Approach to Measure and Assess the Potential Exposure to Airborne Emissions of Engineered Nano-Objects and their Agglomerates and Aggregates (NOAA) at Workplaces 12
Harmonized Tiered Approach Harmonized Tiered Approach to Measure and Assess the Potential Exposure to Airborne Emissions of Engineered Nano-Objects and their Agglomerates and Aggregates (NOAA) at Workplaces 13
Harmonized Tiered Approach: Background/ Assumptions Engineered Nano-Objects (1 100nm) Their Agglomerates and Aggregates (NOAA) (>100nm) Overview of 14 publications that propose strategies to assess airborne NOAA (similarities/ differences); Lack of Occupational Exposure Levels (OELs) (One of a number of scientific unknowns) 14
Harmonized Tiered Approach: Salient Features Approach to assess exposure in workplace; First step to an approach; Not yet validated ; needs to be tested in practice; Overall framework, SOPs and/ or guidance for the different tiers need to be elaborated; Three-tiered approach. 15
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Harmonized Tiered Approach: Three tiers: Tier one: focuses on data gathering (can be limited to a desk top study); Tier two: involves simplified measurements (on site investigation); Tier three: a more intensive measurement effort (on site). 17
Harmonized Tiered Approach: Tier one: Information related to the workplace (numbers of nano objects produced, volume of production, volume of the facility); Information related to the nano objects (composition, handled as powders, aerosols, slurries, or as a nanocomposites); Information related to the activities (processes and handling steps, other processes in the facility, presence or absence of ventilation). 18
Harmonized Tiered Approach: Tier two: Basic exposure or release assessment; Characterises workplace for airborne NOAA using instruments; Also assesses the background; Instrument e.g. Condensation Particle Counter (CPC) 19
Harmonized Tiered Approach: Tier three: To obtain as much information as possible on airborne NOAA; Expert exposure assessment; Realtime and off-line instrumentation e.g. Scanning Mobility Particle Sizer (SMPS); e.g. Condensation Particle Counter (CPC); Chemical analyses; Might lead to risk management measures 20
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Other information Survey on consumer and environmental exposure Occupational safety and health in nanotechnology and Organisation for Economic Cooperation and Development (2009) Murashov et al J. Nanopart Res Science policy considerations for responsible nanotechnology decisions (2010) Morris et al Nature Nanotechnology OECD Workshop on Nanomaterial Exposure Assessment (3 June 2015) on the occasion of the 31 st International Congress on Occupational Safety 22
OECD Nanosafety Team Thank you! Peter Kearns, Mar Gonzalez, Asako Aoyagi, Hoseok Song, Jihane El Gaouzi, Mika Hosokawa. www.oecd.org/env/nanosafety peter.kearns@oecd.org 23