1 OECD and Representative Nanomaterials NIST Workshop on Standards for EHS Research Needs for Engineered Nanoscale Materials September 13, 2007 Jim Willis, Director Chemical Control Division Office of Pollution Prevention and Toxics Chair, OECD Working Party on Manufactured Nanomaterials

2 OECD WPMN Background The Chemicals Committee of the Organisation for Economic Co-Operation and Development (OECD) established a Working Party on Manufactured Nanomaterials (WPMN) effective September, 2006 The objective is to promote international co- operation in health and environmental safety related aspects of manufactured nanomaterials, in order to assist in their safe development –WPMN-1 met in London, October 26-27, 2006 –WPMN-2 met in Berlin, April 26-28, 2007 –WPMN-3 will meet in Paris, November 28-30, 2007 The US (EPA) chairs the working party

3 OECD WPMN Background (2) The WPMN is a subsidiary body of the OECD Chemicals Committee Traditionally, the work of the Chemicals Committee has focused on burden sharing and harmonization, for example –OECD HPV SIDS program –Harmonized test guidelines and mutual acceptance of data Coordination with ISO TC229 is seen as crucial, especially on matters pertaining to materials characterization and standards –Cooperation agreement between OECD and ISO has been developed and agreed

4 Participation Countries: –Australia, Austria, Belgium, Canada, Denmark, European Commission, Finland, France, Germany, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States Observers: –Argentina, China, Israel, Thailand, (Brazil, India, Russia invited) –ISO, WHO, UNEP –BIAC, eNGOs (ED and FOE), WWIC (past) –ICAPO request US Workgroup members: –EPA (OPPT, OPP, ORD), CEQ, OSTP, State, NIH, FDA, NIOSH, OSHA, USDA, NIEHS, USPTO, DOC, CIA, NIST, CPSC

5 OECD Projects The Working Party is working in small steering groups to advance certain specific projects: 1.Development of an OECD Research Database (Australia Chairs) 2.Environmental Health and Safety Research Strategies on Manufactured Nanomaterials (Germany Chairs) 3.Safety Testing of a Representative Set of Manufactured Nanomaterials (US (EPA)/EC Co-Chairs) 4.Manufactured Nanomaterials and Test Guidelines (US (EPA)/EC Co-Chairs) 5.Co-operation on Voluntary Schemes and Regulatory Programmes (Canada Chairs) 6.Co-operation on Risk Assessments (UK Chairs) 7.US-led task to develop a project on Exposure Measurements and Exposure Mitigation (US (NIOSH) Chairs)

6 Project 3 – Safety Testing of a “Representative Set” What to test? For which endpoints? How to test?

7 Representative Nanomaterials What to test? “In commerce, or likely to enter into commerce in the near-term” Governments either (1) don’t have a lot of data on production/import or (2) the data are CBI Approach has been to look at commercial websites for available sales (e.g. nanowerk), and to invite industry to provide views. A number of categories/viable category members became apparent A “work in progress”

8 Representative Nanomaterials Material selection criteria under discussion include: 1.production volume 2.high growth rate 3.potential for human exposure 4.potential for environment exposure 5.extent of data available (incl. from regulatory regimes) 6.comparability to the non nano form 7.opportunities to explore key parameters (e. g. surface charge, surface area) 8.other considerations (e. g. potential for bioavailability as a nanomaterial, integrity of the nano structure)

9 Representative Nanomaterials

10 Representative Nanomaterials Outstanding issues: –Other categories under discussion – quantum dots, nanorods, other inorganic nanoparticles –Other NMs under discussion, eg, NiO, polystyrene –Issues such as surface treatment, modification and functionalization Approach for selecting test materials not yet agreed; options range from: –Industry signs up and selects, to –Surveying NMs in commerce and their characteristics, then selecting “best” NMs Will also need to integrate completed/ongoing testing. Resources include projects 1 and 2, NIOSH NIL, ICON database

11 Endpoints Which endpoints? –Base set in-depth testing on “a few” nanomaterials (up to ~15) Physical-chemical properties Materials Characterization Environmental fate Mammalian toxicity Environmental toxicity Safety –“Shallow” testing add-ons possible, e.g. to investigate effect of changing a variable –Look at in vitro method applicability and validation

12 Possible Identity, P-Chem and Characterization Data Elements Nanomaterial name CAS Number Structural formula/molecular structure Composition of nanomaterial being tested (including degree of purity, known impurities or additives) Quantity (estimated production and/or import volume) [Crystal structure] Physical form at room temperature [Vapor pressure at room temperature] Surface area [Surface energy] Particle size distribution Particle dimensions Solubility Bulk density Agglomeration/aggregation state Porosity Surface charge Surface chemistry Particle density Particle dispersability Stability

13 Project 4 – Test Guidelines How to test? –Need to consider the >100 OECD test guidelines for possible applicability –Need to identify areas where new guidelines are needed –Need to consider the various methods that are out there that can form the basis for new/improved OECD methods –Need to look for opportunities, during the testing program, to develop and/or validate methods

14 Next steps Groups 3 and 4 will meet jointly on October 2-4 in Ispra to finalize a package The 3 rd meeting of the WPMN will be on November in Paris to agree to the package

15 For More Information OECD: