Safer Chemical Assessment Tools Do They Reliably Guide the Selection of Greener Alternatives? Pam Spencer, PhD, DABT Co-Chair, HESI Sustainable Chemical Alternatives Technical Committee HESI Webinar 6 November 2014 Health and Environmental Sciences Institute
Webinar Outline Introduction to HESI Overview of HESI Sustainable Chemical Alternatives Technical Committee 2014 NAS Report: A Framework to Guide Selection of Chemical Alternatives 2015 Opportunities for HESI Technical Committee Q&A 2
HESI Health and Environmental Sciences Institute Creating science-based solutions for a sustainable, healthier world Syril D. Pettit HESI Executive Director ILSI Health and Environmental Sciences Institute
Environmental & Human Health Challenges Foundations, NGOS, Research Institutes Basic discovery research Applied Science Sectors Safety Assessment Safety Assessment Improved Human & Environmental Health
How do we get to GREEN more efficiently?
How do we get to GREEN more efficiently?
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HESI: Growing Innovation Accurate & Efficient Risk Assessment Food Safety ILSI Health and Environmental Sciences Institute 8
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HESI: 2014 Scientific Portfolio > Animal alternatives in environmental risk assessment > Application of genomics to mechanismbased risk assessment > Biomarkers of nephrotoxicity > Cardiac safety > Developmental and reproductive toxicology Genetic toxicology Framework for intelligent non-animal alternative methods for safety assessment SCIENTIFIC COMMITTEES PLUS: Global Platforms Initiative > Immunotoxicology > Protein allergenicity > Risk assessment in the 21 st century (RISK21) > Sustainable chemical alternatives > Use of imaging for translational safety assessment Translational Biomarkers of Neurotoxicity Tiered approach to assess bioaccumulation of chemicals Outreach to provide training and capacity development for improved risk assessment and safety evaluation
HESI HOPE YOU WILL JOIN US! Syril D. Pettit HESI Executive Director www.hesiglobal.org spettit@hesiglobal.org 11
Today s Challenging Landscape Increasing pressures to find more sustainable, safer alternatives Regulatory Drivers: Replace Chemicals of Concern REACH Authorization California Safer Consumer Products Regulation TSCA reform Corporate Sustainability Initiatives Greenhouse gas reduction Energy conservation Raw material preservation Reduced hazard options Customer/Consumer Drivers Banned lists of chemicals Ecolabel certifications 12
Marketplace Trends Marketplace trends in green chemistry Disclosure and assessment of ALL ingredients Focus on hazard reduction Low hazard = safer alternative = greener product Selection of green ; de-selection of hazard-classified products Safer options now being identified outside the regulatory framework Ecolabels are one way that greenness is gauged Today more than 300 separate programs Voluntary substitution, alternative assessment programs, other options 13
HESI Sustainable Alternatives Committee Formed in 2011 Mission: To evaluate and identify key elements/criteria and tools to help trigger and guide the selection of safer, sustainable alternatives while minimizing the likelihood of regrettable substitutions. Objective: The main objective is to develop practical, problemdriven guidance on the conduct of alternative chemical assessment. Workshop: 7-8 February 2013 at NIEHS in North Carolina. Committee Status: The subcommittee was elevated to Technical Committee status by the HESI Board of Trustees in January 2014. 14
2014 Committee Participants ACS Green Chemistry Institute California EPA - DTSC Celanese (Nutrinova) Dow Corning Environment Canada Environmental & Public Health Consulting ExxonMobil George Washington University ICL-IP America, Inc. London School of Economics National Institute of Environmental Health Sciences Novozymes NSF International PE International, Inc. & Five Winds National Institute of Advanced Industrial Science and Technology (Japan) Shell International Soleil Consulting The Dow Chemical Company/Dow AgroSciences LLC Toxics Use Reduction Institute University of Massachusetts, Lowell University of California, Los Angeles University of California, Santa Barbara University of Illinois University of Michigan US Environmental Protection Agency 15
Early Project Objectives Build understanding of existing approaches used to select safer, sustainable alternatives. Identify strengths, weaknesses, and gaps in current approaches. Identify emerging needs/challenges for the future Develop and publish recommendations aimed at improving the successful selection of safer, sustainable alternatives 16
Focus Areas 1. Attributes and tools Attributes beyond hazard that are also important, including life cycle assessment, exposure, risk, performance, cost, and social responsibility New tools for prioritization and assessment of hazard, risk and other attributes 2. Decision-making and weighing Making decisions with limited data and a minimum data set Best practices for weighing disparate attributes 3. Data gaps What are the data gaps and data needs? What are solutions for missing data? 17
Key Accomplishments Workshop, 7-8 February 2013 two manuscripts in preparation: Overview of evaluation of existing frameworks and future needs Decision-making weighing/optimizing choices Outreach numerous conferences SOT, GC&E, ACS, SETAC 18
Alternative Assessment (AA) Frameworks AA Framework Coalition Green Chemistry AA Coalition Document Principles of Alternatives Assessment 2012 DTSC 2012 AA workshop tables Lowell Alternatives Assessment Framework 2006 UBA Guide Sustainable Chemicals UCLA Developing Regulatory AA Methodologies UCSB Safer product alternatives analysis report 2011 TAAG Alternatives Assessment Guidance document Characteristics Framework considers various trade-offs within a sustainability setting (e.g. hazard, risk, LCA implications) Describes tools, data sources and methods for hazard, exposure, and life cycle (environmental, cost and social) assessment. AA methods/frameworks and other background are cited. The framework is designed to evaluate and identify environmentally and socially preferable alternatives. A decision tool for manufacturers, formulators and end users of chemicals. Designed to assist in the selection of sustainable chemicals Decision making framework. Evaluates the application of two primary MCDA (multidecision criteria analysis) tools - multiple attribute utility theory (MAUT) and outranking - were investigated. Compendium of publically available tools, methods and data sources that relate to AA, and relevant background information. Coalition led by Washington State Department of Ecology to development guidance on alternatives assessment for chemicals. Performance/ Cost Attributes Included in AA Hazard Exposure Life-Cycle Considerations X X X X Social X X X X X X X X X X X X X NA NA NA NA NA X X X X X 19
Green Chemicals Screening Tools Tool USEPA Design for the Environment GreenScreen for Safer Chemicals GreenList EcoEfficiency GreenWERCS Characteristics Decision tree approach. Chemicals not passing DfE criteria are not approved by DfE and product is thus not approved. Master Criteria and Functional Class Criteria have been developed. Designed to help select safer chemicals. Decision tree approach that classifies product chemicals into benchmarks e.g., "preferred" versus "avoid". Evaluates chemical and its breakdown products. Used by WalMart, Hewlett Packard, USEPA. Identifies "Preferred" and "Restricted Use" materials. Used by SC Johnson. Compares the life cycles of products or manufacturing processes from cradle to grave. Takes the consumption behavior of end-users into account, as well as various recycling and disposal options." For toxicity, uses EU hazard classification information. Proprietary. Software program that assesses product formulations based on industry and userdefined green criteria. Used by WalMart, others. Performance/ Cost Attributes Included in AA Hazard Exposure Life-Cycle Considerations X X X X X X X X Social 20
Challenges of Green Programs No standard metric across programs to determine greenness Most programs focus primarily on hazard classifications of individual components Other important sustainability criteria are difficult to incorporate Energy and water efficiency Use of renewable feedstocks Assessments can vary by tool/assessor Leads to different/conflicting results Criteria may not adequately discriminate between material profiles to guide best choice(s) of greener product(s) 21
Vision: Information exists to guide sustainable choices Sustainable Choices Future Visioning Life cycle-based Risk-based Hazard-based Present 22
NAS Report: A Framework to Guide Selection of Chemical Alternatives (2014) 1 Charge: Limited to safer chemical substitutes as determined by human health and ecological risks Standard list of endpoints Safety assessment components Phys/chem properties elevated role Human health hazards Ecotoxicity Comparative exposure Life cycle thinking risks beyond point of use or application Optional LCA Performance Economics 1 Board on Chemical Sciences and Technology at 202-334-2187 or visit http://dels.nas.edu/bcst. Copies of A Framework to Guide Selection of Chemical Alternatives are available from the National Academies Press, 500 Fifth Street, NW, Washington, DC 20001 (800-624-6242; www.nap.edu). 23
NAS Report: A Framework to Guide Selection of Chemical Alternatives, cont d. Frameworks reviewed are the same as those reviewed by the HESI SCA Technical Committee Plus: REACH, UNEP and TURI Tools reviewed: GreenScreen, UCLA MCDA Use of novel data streams Tox21 data Research / de novo design Future efforts are needed to develop principles or tools that support the benchmarking and integration of high throughput data on chemical effects. Download the report at http://dels.nas.edu/report/framework-guide-selection/18872 24
From NAS (2014)
Small Pilot Project Highlights Opportunity to Improve Tools 1 EXAMPLE: RESULTS OF CHEMICAL SCREENING TOOLS COMPARISON SCREENING TOOL SCORE GreenWercs (Walmart Scoring Model) GreenWercs (GreenScreen Model) GreenScreen (full assessment) GreenScreen (list translator) USEPA DfE* GreenSuite (preferred) GreenSuite (adjusted*) CHEMICAL NAME Natural Chemical A Natural Chemical B Industrial Chemical A Natural Chemical C Industrial Chemical B Industrial Chemical C 0-2500 (preferable); 2500-6000 (acceptable); 6000-8500 (avoid) 0 (preferable) 0-5000 (preferable); 5000-15000 (acceptable); 15000-20000 (avoid) 6100 (acceptable) 0 (preferable) 2200 (preferable) 0 (preferable) 10700 (acceptable) 0 (preferable) 2200 (preferable) 1700 (preferable) 12700 (acceptable) 0 (preferable) 3200 (preferable) BM1 worst; BM4 best BM2 Moderate Group I Human BM2 High Group II Human BM1 High Group I Human BM1 High Group I Human BM1 High Group I Human/SVHC List U Carcinogenicity LT-1 = BM1; LT- P1 = Possible BM1; LT-U = BM Unspecified LT-1 LT-U (concern - # endpoints of concern) High reproductive and developmental toxicity Approved Safer Ingredient High Eye irritation 0 (most concern) to 100% (no concern) 76.1% 71.55% 86.75% 78.77% LT-P1 No Endpoints of Concern 72.32% 69.01% LT-U LT-1 Very High Eye/Skin irritation Moderate to High Reproductive and developmental toxicity High Reproductive and developmental toxicity Very High Acute and chronic aquatic toxicity 86.22% 75.49% 73.13% 67.01% LT-U TBD 77.8% 67.55% High Developmental Industrial Chemical D toxicity and persistence 0 (preferable) 2500 BM1 LT-1 Very High Acute and (preferable) vbt chronic aquatic toxicity 86.57% 79.05% and bioaccumulation 26 1 Sponsored by American Chemistry Council, Value Chain Outreach Committee, Tools Subcommittee (2014). Publication in preparation.
Potential Sources of Tool Variation Differences in endpoints Type Absolute number Information sources Weighting preferences Handling of data gaps Value judgments 27
Opportunities for HESI SCA Technical Committee LEVERAGE: ACC Pilot and NAS Alternatives Assessment Framework/Recommendations IMPROVE the ability of existing tools to identify sustainable alternatives Identify and demonstrate relevant safety information to inform sustainable choices Build consensus on approaches to reduce sources of variation Build case studies to evaluate and validate tool(s) performance ENHANCE tools by incorporating advances in the science Develop principles or tools to support integration of next gen safety data Demonstrate how exposure data can inform and improve sustainable choices BUILD OUT to include other LCA-like attributes based on established success with hazard and exposure 28
Start Simple, Build Towards More Complex Safety Information Hazard Analysis Safety Assessment Life Cycle Assessment Alternative Assessment Descriptive Information Qualitative Information Quantitative Information Supplemental Information Qualitative Quantitative Information Increasing Confidence in Chemical / Product Evaluation Framework Simple Robust 29
Vision: Information exists to guide sustainable choices Access to and use of hazard, exposure, and other attributes as the basis for product safety evaluations/decisions Risk- and lifecycle-based approaches and tools available Sustainable Choices Future Visioning Life cycle-based Present Risk-based Exposure Hazard-based 30
Phase I Work Plan Plan for workshop in 1Q of 2015 Phase II Develop plan to reduce variability in existing tools Identify tools and develop principles to incorporate next gen safety data Fill data gaps Improve decision making Conduct case studies to evaluate/validate approach leveraging NAS AA Framework Publish case studies Second workshop Develop principles or tools that support the integration of high throughput exposure data Conduct/publish case studies 31
Join the HESI SCA Technical Committee! No cost to participate for the remainder of 2014 2015 company assessment: $6,000 (USD) Committee meets monthly via teleconference To join or request more information, contact: Ms. Brianna A. Farr HESI Scientific Program Associate 202-659-3306, ext. 160 bfarr@hesiglobal.org www.hesiglobal.org 32
QUESTIONS? 33