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 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

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

International Developments Since 2011 OECD ECISO ASTM FDA NSF WHO Nano US EPA NIOSH CPHC update, Oct NSF HAB update, Oct 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 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..”

Precedents in Quantitative Risk Assessment Conventional material The REL 1 for pigment grade TiO 2 is 2.4 mg/m 3 The OSHA PEL for graphite is 5,000 μg/m 3 Nanoscale material The REL 1 for nanoscale TiO 2 is 0.3 mg/m 3 with the designation “potential occupational carcinogen” RELs 2 for carbon nanotubes range from 1 to 50 μg/m 3 1 Recommended Exposure Limit, NIOSH 2 U.S., Japan, and Europe

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

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

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

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