1. NanoRelease and NanoCharacter projects 1

2. Agenda NanoRelease Overview, Work Flow, Project Support and Teams The Need for the NanoRelease Project May 2011 Workshop and Selection of MWCNTs in Polymer Next Steps NanoCharacter The need Plan and who we have signed up Funding sources and needs 2

3. NanoRelease Project Overview Design Multi-stakeholder leadership Open and transparent process Prioritize challenges & needs Review current release literature Solicit expert input on priorities Select first ENM to examine –Parallel efforts welcome… State of Science paper on what we know and can do now Goals Identify best practices for measuring release Use inter-laboratory testing to advance the state of science Validate methodologies and demonstrate transportability Work with Standard Development Organizations to develop standard methodologies for release Transfer technical information to training modules for workplace safety professionals www.ilsi.org/ResearchFoundation/Pages/NanoRelease1.aspx 3

4. 4

5. 5 Phase 2 Structure

6. US Environmental Protection Agency (EPA), Office of Research and Development and Office of Pollution Prevention and Toxics (in kind support) Environment Canada, Emerging Priorities Division Health Canada, New Substances Assessment and Control Bureau American Chemistry Council (ACC), Nanotechnology Panel Society of Chemical Manufacturers & Affiliates National Institute of Standards and Technology (NIST) The Adhesive and Sealant Council American Cleaning Institute Supporting Organizations 6

7. Multi-Stakeholder Steering Committee EPA, National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA), Consumer Product Safety Commission (CPSC), NIST, Health Canada, Environment Canada, Consumers Union, American Chemistry Council, AFL-CIO OECD – WPMN / SG8 INNO:CNT project in Germany NanoImpactNet ANSI / ISO TC229 ASTM E56 Coordination and Outreach 7

8. Landscape of nano-safety Literature - based on NCBI citations 2011 Within these, the number of studies of what is actually released from real-world uses of nanomaterials are far fewer. 8

9. Risk is defined by both exposure and hazard/toxicity To develop safe products we need to measure what is released and characterize it’s relationship to hazard data The science of measuring nanomaterials is evolving, and because there are current risk assessment needs, policy is also evolving Products with nanomaterials in them are on the market now and will shape the policies that are developed for all Why do we care? 9

10. NanoRelease Project Adds Value Provide focus to broad policy debates by working through release scenarios for specific nanomaterials; Examine the full life cycle of solid material uses; Catalogue and disseminate published and unpublished data and methods used to evaluate release scenarios; Develop “state of the science” reports describing what is known and what research gaps exist for understanding nanomaterial releases; Enable improvements, standardization, and widespread use of methods through an inter-laboratory approach to methods improvement. 10

11. Nanomaterial Selection Process 1.A “ multi-voting ” approach ranked nanomaterials during two rounds of voting The results of each round were discussed as a group The list was refined Steering committee members were given time to consult with colleagues. 2.Nanomaterials were sorted into 3 tiers 11

12. Priority Engineered Nanomaterials Tier 1: Multi-walled carbon nanotubes n-Silver n-Titania n-Silica dioxide Tier 2: n-Copper Single-walled carbon nanotubes n-Clays Nanocrystalline cellulose Tier 3: n-Zinc oxide n-Aluminum oxide n-Cerium oxide Quantum Dots Carbon Black 12

13. 50 participants at EPA in Washington DC –US and Canadian agencies (plus EMPA from Switzerland) –Leading industry – general and n-Ag and MWCNT specific –Academics – some doing research that highly overlaps –Non – Governmental Organizations 17 presentations in 4 panels over 2 days –Data sharing needs –n-Ag in textiles –MWCNT in polymer –Methods Breakout sessions –Low hanging fruit –Defining the “release/source term” Presentations are available on the project web site www.ilsi.org/ResearchFoundation/Pages/NanoReleaseMay2011Workshop.aspx May 2011 Workshop to Inform the Steering Committee on which Nanomaterial to Choose 13

14. Lots of specific details on materials and potential methods. Both MWCNT and n-Ag difficult and need this work done – making it a tough choice for the Steering Committee. “Essential project for safe product development” No one asked “why is this needed” This is a leading effort, take advantage of the momentum Pay attention to the context/conceptual model so that we don’t waste opportunities by framing it wrong Can easily get confused by the variety of needs here, so be razor sharp on scope and don’t get side-tracked What We Learned: Enthusiastic Steering 14

15. The selection: MWCNT in polymer In meetings after the Workshop the Steering Committee selected MWCNT in polymer applications We are now selecting the specific polymer to use in methods development, in consideration of applications such as: –Fabrics such as flame-retardant toys & blankets –Tennis racquets, bicycle frames, baseball bats, sports safety equipment –Automobile parts –Boat hulls –Coaxial cable 15

16. 16 Current Plan for MWCNT Test Materials for Phase 3 Methods Development

17. Next Steps Obtaining the carrier system to test –Identifying potential MWCNT carrier systems for testing, implementing procedures, obtaining the system Selecting the methods to compare –Prioritizing best practices to compare with an inter-laboratory approach Selecting the release scenarios of greatest value for consumer products –Weathering, abrasion, cutting, drilling ?? 17

18. 18 Phase 2 Structure

19. NanoCharacter project

20. There are no reporting standards for nano-toxicity or exposure studies Multiple efforts to establish standard approaches: International Groups –International Organization of Standardization TC229 –Organization of Economic Cooperation and Development Working Party on Manufactured Nanomaterials: Guidance for Sponsors “Grass roots” multi-sector: http://characterizationmatters.org/http://characterizationmatters.org/ Sector-specific –Food toxicology: Card, J. W. and Magnuson, B. A. (2009), Letter to the Editor. Journal of Food Science, 74: vi–vii. –Cancer/medical: http://ncl.cancer.gov/working_assay-cascade.asp

21. The European Food Safety Authority Nano Food Guidance, Regarding Characterization Refers to characterization needs at 4 stages of the material –Pristine –In food –For toxicity testing –As in biological fluids Most tests do not have standard methods http://www.efsa.europa.eu/en/efsajournal/pub/2140.htm

22. “The most prominent characteristics of the ENM, as determined by its function, purpose and intended use, should be described and relevant parameters must be determined and provided, according to Table 1.” 22 http://www.efsa.europa.eu/en/efsajournal/pub/2140.htm

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24. Does consistent reporting happen? Nine were chosen for evaluation of the literature for oral toxicity studies by Card et al. 2010 Agglomeration and/or aggregation Chemical composition Crystal structure/crystallinity Particle size/size distribution Purity Shape Surface area Surface charge Surface chemistry (including composition and reactivity ) Card JW, Magnuson BA. 2010. A method to assess the quality of studies that examine the toxicity of engineered nanomaterials. Intl. J. Toxicology 2010 29(4):402-410. Accessible at http://ijt.sagepub.com/content/29/4/402.full.pdf+html. http://ijt.sagepub.com/content/29/4/402.full.pdf+html

25. 21 oral studies of nanomaterials were evaluated for reporting of the 9 characteristics Card JW, Jonaitis TS, Tafazoli S, Magnuson BA. 2010. An appraisal of the published literature on the safety and toxicity of food-related nanomaterials. Critical Reviews in Toxicology: posted online Nov. 16 (doi:10.3109/10408444.2010.524636), accessible at http://informahealthcare.com/doi/abs/10.3109/10408444.2010.524636 http://informahealthcare.com/doi/abs/10.3109/10408444.2010.524636

26. Study246519783 Folkmann et al. (2009)11111 1 Warheit et al. (2007)1111 11 1 1111 11 1 Rohner et al. (2007)1111 1 1 Wang et al. (2007)1111 Bisht et al. (2008)111 11 1 Yoksan and Chirachanchai (2008)111 11 1 Alkilany et al. (2009)111 11 1 Jevprasesphant et al. (2003)111 11 Wang et al. (2008)111 11 Huang et al. (2009)111 1 Koeneman et al. (2009)111 1 El-Sayed et al. (2003)111 1 1 Meng et al. (2007)11 11 11 Chen et al. (2006b)11 11 1 Wang et al. (2006)11 11 Zhang et al. (2001)11 11 Balasubramanyam et al. (2009)11 1 Jia et al. (2005)11 1 Kim et al. (2008)11 1 Yu et al. (2008)11 1 Chan et al. (2009)11 Gajdošíková et al. (2006)11 Zhang et al. (2005)11 Pisal et al. (2008)1 11 1 Mori et al. (2006)1 11 Kitchens et al. (2007)1 1 1 1 Chen et al. (1998)1 1 Xu et al. (2004)1

27. Inconsistent measurement and reporting precludes comparisons Exposure misclassification – exposure and toxicity data can’t be reliably linked Wasted knowledge – data can’t be combined to build knowledge Development risk – new data may not be useful to future assessments Vulnerability to “killer studies” – a hazard study can’t be compared to other nanomaterials We should tread carefully in data or methods development until we know what characteristics data will be needed.

28. NanoCharacter Project Outcomes: A framework and roadmap detailing what needs to be done to gradually adopt characterization consistency for particular domains (e.g., particle toxicology, regulation of food constituents, environmental monitoring, regulation of commodity nanomaterials). Outreach to build consensus on the roadmap internationally, across stovepipes, and across stakeholders (e.g., academics, funders, regulators, industry, and editors or peer reviewers at journals). A multistakeholder panel to monitor and report out (as letters to appropriate agencies and journals) the implementation of the roadmap and to adapt the roadmap as necessary to facilitate adoption of consistent characterization and reporting.

29. The framework lays out the needs of key institutional players, the starting list, the stovepipes, the resource and technology timing issues with respect to characteristics on the list, and the approach to overcoming barriers. The roadmap lays out goals and milestones in consideration of the timing of critical control elements (e.g., funding of research that includes funding of specified types of characterization, funding of methods and instrument development, standardization of methods and regulatory policy adoption, acceptance/adoption by the research community).

30. Framework considerations Support of academia – can laboratories afford the necessary equipment, and are researchers willing to accept the standards? Support of journal editors and peer reviewers – can the technical specifications be applied, will it slow publication? Support and agreement across funding agencies – to require characterization and funding for it Support that spans national and regional boundaries Infrastructure for measurement – standard analysis methods, and availability of advanced instrumentation Cost consideration – phase-in the requirements over time and/or promote the use of user facilities

31. This project will work where others have not: We are not proposing a competing list that gets added to the noise. We will select common elements of the many lists as the starting point in staged implementation We seek only to lay out and follow practical implementation steps We are the first to look across funding, inter-discipline, international, and technical barriers to find solutions Getting leaders of past efforts or thought on the topic allow us to start with a unified front on what to do next, and after that, and after that.

32. Partial funding for Step 1 (framework and roadmap) by Institute of Food Technologists Expert team recruitment so far –Andrew Maynard –Rob Aitken, IOM, UK –Ken Dawson, University College Dublin –Shaun Clancy, Evonik –Ray David, BASF –David Warheit, Dupont –Fred Klaessig, consultant - ISO TC229 –Additional experts to be invited.

33. Funding sources and needs NanoRelease – MWCNT/Polymer Phase 2 through June 2012 –$220k committed from ACC, EPA, Environment Canada, Health Canada –Need $70k – largely for travel and workshop facility/support Need $200k for Phase 3 through mid 2013 –Asked EPA ORD for $50k NanoCharacter Institute for Food Technologists provided $11k seed funding Seeking $30k to complete Roadmap/Framework 33

34. Thank you Richard Canady, PhD DABT Director, RSIA rcanady@ilsi.org www.ilsi.org/RESEARCHFOUNDATION/Pages/RSIA.aspx