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Nanomaterials Issue Paper

Nanomaterials Issue Paper . Standard 61 Joint Committee Meeting December, 2013. Outline. Background Challenges with the current process Trends in risk governance NSF proposes the formation of a task group. Background.

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Nanomaterials Issue Paper

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  1. Nanomaterials Issue Paper Standard 61 Joint Committee Meeting December, 2013

  2. Outline • Background • Challenges with the current process • Trends in risk governance • NSF proposes the formation of a task group

  3. Background • Nanomaterials can be defined as materials with any external dimension in the nanoscale (1-100 nm) or having internal or surface structure in the nanoscale (ISO/TC 229, 2010) • The use of nanomaterials is growing across business sectors including those manufacturing products submitted to NSF for certification • Information to permit evaluation of nanomaterials in these products is not currently required by the relevant NSF/ANSI Standards, including Standard 61

  4. State-of-the-Science: Nanomaterials (2011) • The NSF Council of Public Health Consultants (Oct. 2010) charged the NSF Health Advisory Board to develop a white paper to address concerns for possible novel health risks

  5. International Developments Since 2011 Dec 2012 – WHO concludes that available methodology, current protocols, and testing guidelines for chemical risk assessment could be used to assess nanomaterials, “but they need adaptation..” NSF WHO US EPA Sept 2013 – OECD recommended its Member Countries apply existing international and national chemical regulatory frameworks to manage the risks associated with manufactured nanomaterials adapted to take into account the specific properties of manufactured nanomaterials OECD FDA Nano NIOSH ASTM ISO EC CPHC update, Oct. 2013 NSF HAB update, Oct. 2013

  6. Precedents in Quantitative Risk Assessment Conventional material Nanoscale material The REL1 for nanoscale TiO2 is 0.3 mg/m3 with the designation “potential occupational carcinogen” RELs2 for carbon nanotubes range from 1 to 50 μg/m3 • The REL1 for pigment grade TiO2 is 2.4 mg/m3 • The OSHA PEL for graphite is 5,000 μg/m3 1Recommended Exposure Limit, NIOSH 2U.S., Japan, and Europe

  7. Key Messages • Nanomaterial attributes can influence hazard, exposure, and risk • It is difficult to generalize – risks must be determined on a case-by-case basis • Risk assessment relies on information from producers on: • Use of specific nanomaterials in specific products and; • Potential releases from those products

  8. The Current State Process Does the product contain nanomaterials? Is there release of nanomaterials during foreseeable use? Are current pass/fail criteria appropriate for nanoscale substances? Application of Pass/Fail Criteria Formulation Review Extraction Testing ? ? ?

  9. Current and Emerging Trends • Risk Management - use existing chemical regulatory frameworks and management systems • Increased Transparency – need to disclose material properties, traits; make safety data available to the public • Health Effects Testing • Apply standardized test guidelines adapted as appropriate • Alternative protocols (in vitro toxicity via high throughput /content screening) are anticipated to become an essential component of assessments

  10. Recommendation • Form a nanomaterial task group for drinking water to address the evaluation of nanomaterial-containing products under the relevant NSF/ANSI Standards • Revise Annex A • Identify and communicate information requirements • Design and implement future state process • Include broad representation from manufacturers, certifying bodies, and regulatory members

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