Comprehensive Environmental Assessment of Nanomaterials: A Meta-Assessment Approach

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1 Comprehensive Environmental Assessment of Nanomaterials: A Meta-Assessment Approach J. Michael Davis, PhD Private Consultant (Retired Senior Science Advisor National Center for Environmental Assessment U.S. Environmental Protection Agency Research Triangle Park, NC) Joint SOT RASS / SOT NTSS / SRA ENMSG Webinar January 11, 2012

2 Outline Comprehensive Environmental Assessment (CEA) Framework for organizing complex information Process for prioritizing issues Meta-assessment EPA nanomaterial case studies Next steps 1

3 Comprehensive Environmental Assessment (CEA) Framework and Process 2

4 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Health Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 3

5 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Health Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 4

6 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling R & D Laboratory standard procedures: applicable? Transport/Transformation/Fate Feedstock Processing Raw materials and waste by-products Primary and Secondary Substances MEDIA air water biological Manufacturing Includes primary nano constituents and associated materials social Humans Other Biota Abiotic Resources Storage / Distribution Routine and accidental releases Use Consumer and occupational Health Disposal / Recycling Not always predictable Exposure-Dose Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 5

7 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Health Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 6

8 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water Transport Movement of nanomaterials and waste by-products from points of release biological social Exposure-Dose Humans Other Biota Abiotic Resources Transformation Natural features, structures, painted surfaces, etc. Physical/chemical changes of primary substances into other (secondary) substances sediment soil Impacts Fate Environmental occurrence Health of primary Ecological and secondary substances, Other including persistence, degradation, and other phenomena Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. 7

9 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Health Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 8

10 CEA: Framework physical chemical currents biological social Cradle CONDITIONS Physical: e.g., temperature, wind/water Chemical: e.g., ph, interaction with other chemicals in the environment R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Humans Other Biota Abiotic Resources Biological: e.g., natural organic matter, bacteria Social: e.g., human behavior patterns, policies, and practices Health Product Life Cycle Primary and Secondary Substances Exposure-Dose Impacts Ecological Other Grave MEDIA Natural features, structures, painted surfaces, etc. Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. air Air: e.g., microenvironment, ambient water Water: e.g., natural, waste-water, freshwater, marine, surface, subsurface Sediment: e.g., fluvial, marine, aeolian, sludge Soil: e.g., type, location, function sediment soil 9

11 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Health Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 10

12 CEA: Framework physical chemical Product Life Cycle Cradle Grave Humans R&D - Feedstock Processing - Manufacturing - Populations (e.g., distribution Storage/Distribution of personal - Use - exposures, Disposal/Recycling define sensitive groups) Routes (e.g., inhalation, oral, dermal) Aggregate CONDITIONS dose (same substance via multiple pathways) MEDIA Cumulative dose (multiple associated substances) Transport/Transformation/Fate Other Biota Flora and fauna (species, Primary populations, and Secondary communities, Substances ecosystems) Bioavailability air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Abiotic Resources Natural features (e.g., visibility, landscape) Impacts Structures (e.g., Health buildings, statuary) Ecological Painted surfaces (e.g., vehicles, metal roofs) Natural features, structures, painted surfaces, etc. Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. soil 11

13 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Health Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 12

14 CEA: Framework Cradle Grave R&D - Feedstock Processing - Manufacturing - Health Storage/Distribution - Use - Disposal/Recycling Subcellular (e.g., genetic, enzyme) Whole organism (e.g., cancer, reproduction, development, neurobehavior) Population CONDITIONS (e.g., morbidity/mortality rates) physical chemical biological Transport/Transformation/Fate Humans Other Biota Abiotic Resources Health Product Life Cycle Exposure-Dose Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. MEDIA Ecological Direct impacts (e.g., survival, growth, reproduction, gene expression, oxidative stress) Indirect impacts (e.g., pore Primary clogging, and solubilization Secondary Substances of toxics, ROS production) Other Aesthetic (e.g., building façade degradation) Climate (e.g., GHG production) Energy (e.g., oil use) Ethical-Legal-Social (e.g., environmental justice) Resource (e.g., land depletion, water use) social Sustainability (e.g., green production) air water sediment soil 13

15 CEA: Framework physical chemical CONDITIONS Product Life Cycle Cradle Grave R&D - Feedstock Processing - Manufacturing - Storage/Distribution - Use - Disposal/Recycling Transport/Transformation/Fate Primary and Secondary Substances MEDIA air water biological social Exposure-Dose Humans Other Biota Abiotic Resources Health Natural features, structures, painted surfaces, etc. Impacts Ecological Other Aesthetic, Climate, Energy, Ethical-Legal-Social, Resources, Sustainability, etc. sediment soil 14

16 CEA Framework: Conceptual Model Illustration for Nano-Silver 15

17 16 CEA Framework: Conceptual Model Illustration Extended

18 CEA Framework: Key Features Holistic, systematic but each case is individual: no a priori boundaries not just a check list Qualitative and quantitative: uses quantitative data and analyses when possible but is not restricted to quantitative includes qualitative data and analyses Includes direct and indirect impacts: secondary by-products (wastes, transformation products) interactions with other substances Comparative: alternative choices risks vs. benefits 17

19 Compile Information in CEA Framework CEA: Process Collective Judgment Based on Diverse Perspectives Prioritize Information Gaps Prioritize Risk Trade-Offs Assess Research Develop Research Plan Conduct Research Risk Develop Risk Management Plan Monitor, Evaluate Outcomes Manage 18

20 Compile Information in CEA Framework Holistic Identifies priorities Supports research and risk management Iterative Research Develop Research Plan Conduct Research Collective Judgment Based on Diverse Perspectives Prioritize Information Gaps Prioritize Risk Trade-Offs Risk Develop Risk Management Plan Monitor, Evaluate Outcomes Assess Manage 19

21 CEA Process: Key Features of Collective Judgment Aspect Structured: 1) avoids domination by loudest voice; all participants contribute equally 2) avoids group think; participants remain independent 20 20

22 Key Features of CEA Collective Judgment (cont d.) Interactive: Participants may learn from other perspectives Combined insights of diverse participants: Better results than small number of inbred experts Transparent: Explicit inputs & outcomes, not subjective interpretation 21

23 CEA as Meta-Assessment Framework incorporates and builds on life cycle analyses exposure assessments hazard analyses risk characterizations other analyses and information Process enables integration of complex, possibly contradictory info avoidance of paralysis by analysis highlighting key trade-offs for risk managers 22

24 Compile Information in CEA Framework CEA: applied to nanomaterial research Collective Judgment Based on Diverse Perspectives Prioritize Information Gaps Prioritize Risk Trade-Offs Assess Research Develop Research Plan Conduct Research Risk Develop Risk Management Plan Monitor, Evaluate Outcomes Manage 23

25 Nanomaterial Case Studies Nanoscale Titanium Dioxide Nanoscale Silver Water Treatment Sunscreen Disinfectant Spray Case study documents & workshops 24

26 Nanomaterial Case Studies Structured by CEA Framework and intended as foundation for CEA Process Chapters on product life cycle, fate, exposure, effects Info gaps noted as starting point for collective judgment prioritization Not an assessment; focus on research planning Info gaps identified for: Specific nanomaterial (but across applications) Type of nanomaterial (e.g., metal oxides) Nanomaterials generally 25

27 Nominal Group Technique: Applied in Nanomaterial Workshops Review Case Study before workshop Roundrobin : Equal time to each person Group consolidates related issues Vote for top priorities 26 Workshop Focus: Identify & Prioritize information needed to complete a CEA of specified nanomaterial product

28 Priority Themes from Nanomaterial Case Study Workshops 27 Physicochemical characterization Identify key properties Develop / apply methods Relate to life cycle stages, fate & transport, matrices, exposure, effects Effects characterization (ecotoxicity, human health) Standardize / harmonize test protocols, acute / chronic Reference materials Mechanisms Exposure characterization Sources / life cycle stages, pathways, routes Most susceptible species / populations 27

29 Accomplishments Nano-TiO 2 Workshop: Sept , 2009 Nano-TiO 2 Case Studies: Water Treatment and Topical Sunscreen (final), November 2010 Nanoscale Silver Case Study: Disinfectant Spray (external review draft): August 2010 Nano-Silver Workshop: Jan. 4-7,

30 Next Steps Nanoscale Silver Case Study: final document Nanoscale Carbon Case Study Comparing nano- and non-nano-enabled products Workshop and/or web-based process for collective judgment of nano-carbon research priorities Develop interactive conceptual model of CEA Long-range research strategy for comprehensive environmental assessment of nanomaterials Extends EPA/ORD Nanomaterials Research Strategy Relevant to entire scientific community, not just EPA Dynamic, evolving document 29

31 Compile Information in CEA Framework CEA: applied to risk management support Collective Judgment Based on Diverse Perspectives Prioritize Information Gaps Prioritize Risk Trade-Offs Assess Research Develop Research Plan Conduct Research Risk Develop Risk Management Plan Monitor, Evaluate Outcomes Manage 30

32 CEA Assessment Possibilities Biofuel issues, e.g., Biodiesel feedstocks Ethanol net energy gain/loss Metal fuel additives in Europe DoD materiel acquisition decisions SynBio, e.g., GMOs 31

33 The EPA/ORD/NCEA Nanomaterial Case Studies Team* J. Michael Davis (Team Leader, retired) Maureen Gwinn Amy Wang Christine Hendren Tom Long Patricia Gillespie Genya Dana Christy Powers *Chronological order from

34 For more information Davis, J. M. How to assess the risks of nanotechnology: learning from past experience J. Nanosci. Nanotechnol. 7(2): , 2007 U.S. EPA. Nanotechnology White Paper. U.S. Environmental Protection Agency, Washington, DC, EPA/100/B-07/001, U.S. EPA. Nanomaterial Research Strategy. U.S. Environmental Protection Agency, Washington, DC, EPA/620/K-09/011, U.S. EPA. Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen (Final). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/057F,

35 For more information (cont d) U.S. EPA. Workshop Summary for the EPA Board of Scientific Counselors; Nanomaterial Case Studies Workshop: Developing a Comprehensive Environmental Assessment Research Strategy for Nanoscale Titanium Dioxide, September 29-30, U.S. Environmental Protection Agency, Research Triangle Park, NC, EPA/600/R-10/042, U.S. EPA Board of Scientific Counselors. Letter dated August 31, 2010 re: review of the ORD Nanomaterial Case Studies Workshop held September 29-30, U.S. EPA. Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-10/081, U.S. EPA. Comprehensive Environmental Assessment: A Meta-Assessment Approach to Increase Effectiveness of Risk Management and Research Planning. U.S. Environmental Protection Agency, Washington, DC 34

36 Questions or Comments? Contact information: Mike Davis For information on EPA nano case studies and CEA development/application: Christy Powers 35

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