Assessing the Risks of Nanomaterials
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1 Assessing the Risks of Nanomaterials J. Michael Davis, Ph.D. Senior Science Advisor National Center for Environmental Assessment U.S. Environmental Protection Agency Research Triangle Park, NC Auditing Roundtable Phoenix, Arizona January 7, 2008
2 Outline Overview of organizations and activities relevant to nanotechnology Environmental, Health, and Safety issues EPA Case Studies for development of a Comprehensive Environmental Assessment Research Strategy for Nanomaterials
3 Federal Context for Nanotechnology President s Office of Science and Technology Policy (OSTP) National Science and Technology Council (NSTC) Nanoscale Science, Engineering, and Technology Subcommittee (NSET) National Nanotechnology Initiative (NNI) Nanotechnology Environmental and Health Implications Working Group (NEHI)
4 National Nanotechnology Initiative National Nanotechnology Initiative (NNI) ( coordinates R&D of 20+ federal agencies funds university research supports commercial development Note: Applications funding >>> Implications funding Nanotechnology Environmental and Health Implications Working Group (NEHI) coordinating role for federal EHS research Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials (2006) (
5 Federal Nanotechnology R&D DOD DOE EPA FDA NASA NIEHS NIOSH NIST NSF USDA et al.
6 Other Activities Related to Nanotechnology Environmental Defense - DuPont Nano Risk Framework ( Woodrow Wilson Center ( International Council on Nanotechnology / Center for Biological and Environmental Nanotechnology (Rice University) ( Organisation for Economic Co-operation and Development (OECD) ( European Union (EU) ( United Kingdom Royal Society ( ISO / ANSI / ASTM
7 OECD Program on Safety of Manufactured Nanomaterials Objective: promote international cooperation in EHS-related aspects of manufactured nanomaterials Workgroups: Development of EHS research database Research strategies Safety testing of representative materials Testing guidelines Cooperation on voluntary and regulatory efforts Cooperation on risk assessments and exposure measurements
8 EPA Organizational and Regulatory Context for Nanotechnology Issues Office of Air and Radiation (OAR) Clean Air Act (CAA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS) Toxic Substances Control Act (TSCA) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Office of Solid Waste and Emergency Response (OSWER) Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) Resource Conservation and Recovery Act (RCRA) Office of Water (OW) Clean Water Act (CWA) (ORD) Science Policy Council / Nanotechnology Workgroup
9 EPA Regulatory Authorities Toxic Substances Control Act (TSCA) Pre-Manufacture Notice (PMN) Significant New Use Rule (SNUR) Nanoscale Materials Stewardship Program ( Stewardship Program Concept Paper Information Collection Request TSCA Inventory Approach Paper Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Pesticide Registration: Clarification for Ion Generating Equipment (
10 Selected EPA Efforts Related to Nanotechnology R&D STAR grants ( NSF/EPA rfp for a Center for the Environmental Implications of Nanotechnology ORD Nanomaterials Research Strategy (Draft) EPA Nanotechnology White Paper (2007) EPA Nanomaterial Case Studies for Comprehensive Environmental Assessment
11 EPA Nanotechnology White Paper (Feb. 2007): Key Recommendations Environmental applications research Risk assessment research Physicochemical characterization Environmental fate Environmental detection and analysis Potential releases and human exposure Human health effects assessment Ecological effects assessment Case studies Pollution prevention, stewardship, sustainability Collaboration and leadership Intra-agency workgroup Training
12 Comprehensive Environmental Assessment (CEA) CEA LC + RA LC: Product Life Cycle framework RA: Risk Assessment paradigm See: Davis, J. M. How to assess the risks of nanotechnology: learning from past experience J. Nanosci. Nanotechnol. 7(2): , 2007
13 Product Life Cycle Feedstocks Manufacturing Distribution Storage Use Disposal
14 Risk Assessment Dose-Response Assessment Hazard Identification Risk Characterization Exposure Assessment
15 Comprehensive Environmental Assessment (CEA) Life Cycle Stages Environmental Pathways Fate & Transport Exposure Effects Feedstocks Manufacture Air Water Primary contaminants Biota Eco-systems Distribution Storage Soil Secondary contaminants Human populations Human Health Use Food web Disposal
16 CEA Features Qualitative > quantitative Comparative: Alternative choices Risks vs. benefits Guidance to risk managers: Highlights trade-offs Focus for monitoring, mitigation Adaptive management Identifies: Information gaps Research priorities
17 Process Focus on draft case studies Obtain variety of technical & stakeholder perspectives Use expert judgment methods Repeat periodically
18 Case Studies EPA Nanotechnology White Paper (2007) recommendation Goal: identify & prioritize research needed for comprehensive environmental assessment of nanomaterials Selected classes of nanomaterials: Nanoscale titanium dioxide (nano-tio 2 ) Single-wall carbon nanotubes (SWCNT)
19 Case Studies (cont d.) Specific Applications within Classes of Nanomaterials: CS#1 nano-tio 2 for water treatment CS#2 nano-tio 2 in sunscreen SWCNT application(s) not yet determined Note: Case Studies are not completed assessments
20 Summary of Acute nano-tio 2 Aquatic Toxicity Tests TEST Material Study Endpoint Value EPA / OPPT Hazard Ranking Acute aquatic invertebrate (daphnids) THF nm anatase EPA 48h tox test (Lovern and Klaper 2006) LC 50 (48 hr) 5.5 mg/l M Acute aquatic invertebrate (daphnids) THF-30 nm anatase EPA 48h tox test (Lovern and Klaper 2006) NOEC 2.0 mg/l M Acute aquatic invertebrate (daphnids) sonicated >100 nm anatase EPA 48h tox test (Lovern and Klaper 2006) LC 50 (48 hr) NA L Acute aquatic invertebrate (daphnids) unspecified nano-tio 2 OECD 202 (Wiench et al. 2007) EC 50 NA L Acute aquatic invertebrate (daphnids) 140 nm 79% rutile: 21% anatase OECD 202 (Warheit et al. 2007b) EC 50 (48h) >100 mg/l L Acute algal toxicity 140 nm 79% rutile: 21% anatase OECD 201 (Warheit et al. 2007b) EC 50 (72hgrowth) 21 ± 5 to 87 ± 4 mg/l M Acute algal toxicity 380 nm rutile OECD 201 (Warheit et al. 2007b) EC 50 (72hgrowth) 16 ± 6 to 61 ± 9 mg/l M Acute fish toxicity test 140 nm 79% rutile: 21% anatase OECD 203 (Warheit et al. 2007b) LC 50 (96h) >100 mg/l L Acute Algal toxicity 25 nm P25 (~80% anatase: 20% rutile) EU standard algal assay (Hunde-Rinke and Simon 2006) EC mg/l M (harmful according to EC) Acute Algal toxicity 100 nm anatase (Hombikat) EU standard algal assay (Hunde-Rinke and Simon 2006) EC 50 NA L
21 CEA Case Study Water Treatment Scenario A Life Cycle Stages Environment Pathways Fate & Transport Exposure Effects Feedstocks Manufacture Air Primary contaminants Eco-systems Distribution Storage Water Soil Secondary contaminants Aggregate Cumulative Human Health Use Disposal Food web
22 CEA Case Study Water Treatment Scenario B Life Cycle Stages Environment Pathways Fate & Transport Exposure Effects Feedstocks Manufacture Distribution Air Water Primary contaminants Respiratory Oral Eco-systems Storage Soil Secondary contaminants Dermal Human Health Use Disposal Food web Injection
23 Current Status / Next Steps Currently: Draft CS#1 (water treatment) in limited external review and development Draft CS#2 (sunscreen) in review by internal workgroup Planned: Public comment / input Workshop Report (Comprehensive Research Strategy)
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