GHS Webinar Series Module 2: Business Implications. Thursday, January 15, 2015

Transcription

1 GHS Webinar Series Module 2: Business Implications Thursday, January 15, 2015

2 Module 1 Recap GHS has been inconsistently implemented around the world Currently 24 jurisdictions have adopted some form of GHS under 1 or more regulatory programs In addition to the inconsistent application of GHS, hazards for same CAS# may differ for a variety of reasons e.g., professional judgment, data access, and presence of impurities Given complexities, companies should develop an integrated assessment plan with legal, business and scientific input Document decisions and efforts to comply with country-specific requirements Plan resources accordingly gy 2

3 Recap and Introduction Module 1 Module 2 Take Home Message Introduction Meeting GHS requirements is not straightforward on multiple fronts Can require extensive management resources and technical expertise Meeting GHS requirements is the "heavy lifting" Leverage GHS compliance work into proactive product stewardship program Prepare for market/regulatory pressures that are increasingly demanding "greener" products 3

4 Today s Speakers Kim Reid Practical Applications of the GHS Hazard Assessment in Product Stewardship: Challenges and Implications Tim Verslycke GHS Compliance Turned Product Stewardship Program Tom Lewandowski Regulations Requiring Alternatives Assessments and Tools for Conducting Them 4

5 Practical Applications of the GHS Hazard Assessment in Product Stewardship: Examples, Challenges and Implications GHS Webinar Series- Module 2 Presentation 1 Kim Reid kreid@gradientcorp.com Gradient January 15, 2015

6 Agenda Role of Hazard Assessment in Product Stewardship Examples of GHS based Product Stewardship Tools Challenges Future Outlook Summary 6

7 Shifting Focus from Risk to Hazard-Based Chemical Assessments Risk assessment has driven chemical safety for many decades, BUT The current trend in chemical assessment emphasizes hazard, NOT risk By eliminating the hazard, exposure is no longer a concern 7

8 Defining Hazard Assessment A review of the various hazard properties for chemicals in products Taken a step further Product stewardship tools can be used to leverage existing hazard assessments & GHS compliance data Evaluate or "rank" products based on overall ingredient hazards Focus on hazard (inherent properties) without considering exposure Ordering is a challenge, which properties (human tox, ecotox, physical safety, etc.) have priority? 8

9 Hazard Assessment in Product Stewardship Increasingly prevalent as companies, regulators and the public seek to understand the hazards chemicals may pose Critical to upstream and downstream supply chain management Very consumer-driven, and companies are responding to heightened consumer pressure Regulatory compliance also an obvious driver Walmart Target Whole Foods HP Halliburton SC Johnson NIKE 9

10 Hazard Assessment in Product Stewardship With increased focus on Green Chemistry and sustainable product life-cycles, numerous stakeholders have developed tools and approaches to Scrutinize i each chemical used din a product or formulation Perform comprehensive evaluations of human toxicity, environmental toxicity, and physical safety Leverage existing data & information 10

11 Walmart TM Responds to Retail Market Pressures Ui Using Hazard dassessment Walmart Policy on Sustainable Chemistry in Consumables Guiding principle: eliminate the use or generation of hazardous substances, both to humans and the environment Require suppliers to provide online public ingredient disclosure Develop list of priority chemicals, for continuous reduction, restriction, and elimination Sell private brand cleaning products in accordance with the US EPA s Design for the Environment Safer Product Labeling program 11

12 Target Responds to Retail Market Pressures Using Hazard Assessment Target Sustainability Product Standard Partnered with UL s GoodGuide in 2013 to create a rating systems for consumer products Products receive a score (scaled 1-10) 10) based on ingredients and transparency, and environmental impact Began with Personal Care, Beauty, Household Cleaning, and Baby Care, moved to Cosmetics in 2014 To date, information on 12 Target products published on GoodGuide s website along with information on ingredient disclosure and data adequacy 12

13 Product Stewardship Tools A Primer Multiple stakeholders (inc. regulatory & industrial sectors) have developed approaches and tools to assess chemical hazards Overwhelming number of tools are available Some publicly available, others proprietary/licensed Numerous types of approaches are available Ranking/Scoring Green Chemistry & Product Assessment Choosing the appropriate tool depends on one s overall objective Hazard screening Alternatives assessment Life-cycle analysis/sustainability Product certification/labeling 13

14 Product Stewardship Tools A Primer (cont.) Tools share many similar characteristics, but each approach is slightly different Data sources Outputs Degree of training i needed d Tools are available in a variety of platforms Documented decision frameworks/guidance (US EPA DfE, Clean Production Action s GreenScreen TM ) Automated or semi-automated software programs (Chemistry Scoring Index (CSI); SciVera Lens, GreenWercs) Database/lists (Pharos) Many tools rely on accepted guidance and criteria (e.g., UN GHS) 14

15 Tool Selection Can Be a Challenge Most (but not all) systems evaluate intrinsic hazards and do not quantify exposure and risk All of this can create a very confusing landscape for stakeholders! 15

16 GHS-Based Product Stewardship Tools Beyond implementation, compliance, and "Classification and Labeling" GHS criteria and classifications form the basis for assigning hazards "Global Harmonization" promotes consistency Allows companies to leverage data & information they already have Product stewardship tools generally evaluate the three main GHS categories and associated subcategories Human Health Environment Physical Safety 16

17 GHS Hazard Categories Rev. 5 Environment Human Health Physical Safety Acute Aquatic Toxicity Acute Toxicity Explosive Chronic Aquatic Toxicity Skin Damage Pyrotechnic Bioaccumulation Eye Damage Flammable Gas Biodegradation (persistent/inherent) Reproductive Toxicity Oxidizing Gas Ozone Hazard Mutagenicity Gases Under Pressure Carcinogenicity Flammable Liquid (Category 1-4) Sensitizer Acute Target Organ Toxicity Chronic Target Organ Toxicity Aspiration Hazard Globally Harmonized System of Classification and Labeling of Chemicals (GHS) 17 Flammable Solid Self-Reactive Substance Pyrophoric (Liquids and Solids) Self-Heating Substance Emit Flammable Gases in Contact with Water Oxidizing Liquid Oxidizing i Solid Organic Peroxide Corrosive to Metals

18 Examples of GHS-based Product Stewardship Tools US EPA Design for the Environment (DfE) Clean Production Action (CPA) GreenScreen TM Chemistry Scoring Index (CSI) 18

19 Example 1: EPA Design for the Environment (DfE) Safer product label for products meeting EPA-defined standards and criteria Products undergo a screening evaluation performed by a certified third party using documented criteria (requires full ingredient disclosure) Criteria defined for Functional Classes (chelating/sequestering, surfactants, fragrances, etc.) and specific product categories (direct-release products, personal care products) 19

20 Example 1: EPA Design for the Environment (DfE) GHS-based "Master Criteria" exist for evaluating active ingredients that do not fall into functional classes Considers Human Health and Environmental Toxicity only (not Physical Hazards) Products for which all chemicals pass screening criteria may be eligible for the DfE label Harmonized with Clean Production Action s GreenScreen TM criteria 20

21 Example 2: GreenScreen TM for Safer Chemicals Published by Clean Production Action, a non-profit organization ( Considers the three main GHS categories of human health, environmental, and physical hazards and assigns a score to individual endpoints Considers not only the chemical, but also any relevant transformation or degradation products Chemicals are placed into one of four "benchmarks" Chemicals are "screened" based primarily on lists of chemicals with hazardous properties or regulatory significance 21

22 Example 2: GreenScreen TM for Safer Chemicals AfullGreenScreen TM chemical profile can also be performed; this involves a thorough literature search/review, weight-of-evidence analysis, and professional judgment by a trained toxicologist Certification option is available for some users Generally performed by certified third-party (Gradient is in process of becoming certified) 22

23 GreenScreen TM Benchmarks Benchmark 4 Benchmark 2 Benchmark 2 Benchmark 3 Prefer Safer Chemical Benchmark 4 Use but Still Opportunities for Improvement Use but Search for Safer Substitutes Criteria are increasingly more demanding as Benchmarks increase, thus Benchmarks 3 and 4(thesafest chemicals) set the bar high Benchmark 1 Avoid Chemical of High Concern 23 Source: Clean Production Action

24 Example GreenScreen TM Benchmark Analysis Priority Human Effects 2 Ethyl-1-Hexanol (CAS ) Other Human Effects C M R D E AT ST N SnS SnR IrS IrE single repeated single repeated L L dg M dg M dg L dg dg L dg M H EcoTox Env Fate Physical AA CA P B Rx F M L vl vl L M Greater weight given to priority human effects (carcinogenic, mutagenic, repro/developmental and endocrine) Data gaps (dg) can worsen score (depending on number/category) Overall Assigned Benchmark 2 ("Use but search for alternatives") Based on moderate developmental toxicity (from worst case study, ignores some negative studies); also moderate acute toxicity (health) and acute aquatic toxicity (eco) 24

25 Example 3: Chemistry Scoring Index (CSI) Semi-automated spreadsheet tool originally developed for the oil and gas industry but applicable to other sectors Allows for hazard comparison between products within the same product use group Considers the 3 main GHS hazard categories Environmental + Physical + Health Implements GHS criteria for toxicity endpoints, but also considers a few more categories More on this tool will be discussed in the next presentation 25

26 Challenges Some product stewardship tools are highly conservative or precautionary (limited consideration of data quality, conflicting results) Lack of data (data gaps) can worsen the hazard classification or score Results can be easily misinterpreted Without considering exposure, might a less hazardous alternative actually have higher risk? 26

27 What Can We Expect Moving Forward? More and more companies will likely adopt Hazard Identification and Hazard Assessment as policy Risk reduction policies, supply chain pressures, competitive advantages Hazard identification will be increasingly prominent in regulatory efforts EU rules, California s Safer Consumer Product regs, more states to follow, TSCA reform? Results of GreenScreen TM and similar product stewardship tools may be relied upon in litigation, press releases, etc. 27

28 In Closing There is increased prevalence of fghs-based productstewardship tools and their use by stakeholders Regulatory drivers Basic regulatory requirements associated with traditional chemical management Emerging requirements associated with "green" chemistry initiatives Market drivers Consumer demands for "green" products Platform to build on product stewardship issues Business Implications Need for increased disclosure of chemicals and hazards (i.e., DfE) Moving target for stakeholders (CA regulations, upstream/downstream stewardship policies) 28

29 Questions? Kim Reid Gradient Cambridge, MA, USA 29

30 GHS Compliance Turned Product Stewardship Program GHS Webinar Series- Module 2 Presentation 2 Tim Verslycke, Ph.D. Gradient January 15 th, 2015

31 Leverage Your GHS Data Meeting GHS requirements can require extensive management resources and technical expertise Compiling required GHS information is the "heavy lifting" Leverage your GHS data! Internally: formulate safer products, compare chemical/product alternatives, identify key datagaps Externally: communicate to clients/consumers, create market advantage How? 31

32 The Chemistry Scoring Index (CSI)

33 CSI Why? Large portfolio of chemicals and products needed to meet the wide range of performance requirements of the oil and gas industry Chemicals in this portfolio exhibit a wide range of potential hazards to human health, safety, and the environment (HSE) Increased scrutiny from regulators, environmental groups, the public, and other stakeholders Industry is increasingly incorporating "greener" products and practices in response Broadly-accepted approaches for selecting "greener" or safer chemicals and products are lacking 33

34 CSI Objective Develop a globally implementable tool that comprehensively scores and ranks products used in oil and gas operations based on their potential human health, safety, and environmental (HSE) hazards 34

35 CSI Hazard Criteria Human Health Physical Safety Environment 35

36 CSI Hazard Categories Environment Human Health Physical Safety Acute Aquatic Tox (Cat. 1-3) Carcinogenicity (Cat. 1-2) Explosive Chronic Aquatic Tox (Cat. 1-4) Mutagenicity Pyrotechnic Bioaccumulation i Reproductive Toxicity i Flammable Gas Biodegradation (persistent/inherent) Sensitizer Oxidizing Gas Ozone Depleting Substance Acute Toxicity (Cat. 1-4) Gases Under Pressure Endocrine Disruptor Corrosivity (Cat. 1-2) Flammable Liquid (Cat. 1-4) Volatile Organic Compound (VOC) Acute Target Organ Toxicity Flammable Solid Hazardous Air Pollutants Chronic Target Organ Toxicity Self-Reactive Substance Hazardous Water Pollutants Aspiration Hazard Pyrophoric (Liquids and Solids) 36 Self-Heating Substance Emit itflammable Gases in Contact with Water Oxidizing Liquid Oxidizing Solid Organic Peroxide Corrosive to Metals

37 CSI Hazard Category Assignment Hazards assigned for each category based on a Minimum Set of Lists that are contained within the LOLI (List Of Lists) Database A subscription service database, developed dand maintained dby ChemADVISOR, Inc. Continuously updated Contains >5,000 regulatory lists from 117 countries around the world, including environmental, health and safety, international, inventories, and reference material used for Safety Data Sheet (SDS) preparation 37

38 38 CSI Hazard Category Assignment LOLI

39 CSI Product Scoring CSI Scoring Matrix Specifies scores for each assigned hazard category based on the percentage of that chemical in the product Also assigns scores to components for which data are not available 39

40 CSI Product Scoring Matrix Hazard Criteria ENVI IRONMEN NTAL Hazard Categories Max. Score Product Component Percent Range >0-0.09% % 1-4.9% 5-9.9% % % % Do not Do not No Data Available evaluate evaluate Acute Aquatic Toxicity Cat Acute Aquatic Toxicity Cat Acute Aquatic Toxicity Cat Ozone Depletion Volatile Organic Compounds Hazardous Air Pollutants Hazardous Water Pollutants Biodegradation - Persistent Biodegradation - Inherent Bioaccumulation Endocrine Disruptors No Hazard

41 CSI Product Scoring Matrix Hazard Criteria PHY YSICAL Hazard Categories Max. Score Product Component Percent Range >0-0.09% % 1-4.9% 5-9.9% % % % Do not No Data Available Do not evaluate evaluate Explosive Organic Peroxide Flammable Gas Flammable Liquid Cat Flammable Liquid Cat Flammable Liquid id Cat Flammable Liquid Cat Flammable Solid Oxidizing Gas Oxidizing Solid Pyrotechnic Pyrophoric (Liquids and Solids) Oxidizing Liquid Self-Reactive Substance Gases Under Pressure Self-Heating Substance Emit Flammable Gases in Contact with Water Corrosive to Metals No Hazard

42 CSI Product Scoring Matrix Hazard Criteria HEALTH H Hazard Categories Max. Score Product Component Percent Range >0-0.09% % 1-4.9% 5-9.9% % % % Do not Do not No Data Available evaluate Carcinogenicity Cat Carcinogenicity Cat Acute Toxicity Cat Acute Toxicity Cat Acute Toxicity Cat evaluate Acute Toxicity Cat Mutagenicity Reproductive Toxicity Acute Target Organ Toxicity Chronic Target Organ Toxicity Sensitizers Corrosivity Cat Corrosivity Cat. 2 (Irritant) Aspiration Hazard No Hazard

43 CSI Product Scoring CSI Score = Environmental Score + Physical Score + Health Score CSI Product Score Allows for hazard comparison between products within the same product use group (e.g., emulsifiers, foaming agents, proppants, surfactants, corrosion inhibitors ) Products that score lower within a product use group are considered to have a lower intrinsic hazard compared to other products within the same use group that have higher scores 43

44 CSI Product Scoring Example Prod Comp % Mass* Environmental Hazards Physical Hazards Health Hazards CSI Scores 1 A 1-4.9% No Data Available (50) No Data Available No Data Available (50) ENV = 250 B % PHY = NA Acute Aq Tox Cat. 1 (100) Acute Tox Cat. 2 (75) HEA = 200 Biodegradation - Persistent (50) No Data Available Corrosivity Cat. 1 (25) TOTAL = NA Bioaccumulation (50) Chronic Target Organ Tox (50) Flammable Solid Acute Tox Cat. 2 (75) ENV = 200 Acute Aq Tox Cat. 1 (100) (75) Corrosivity Cat. 1 (25) PHY = 125 Biodegradation - Persistent (50) Self-Reactive Acute Target Organ Tox (50) Bioaccumulation (50) 2 C % 3 D 1-4.9% Acute Aq Tox Cat. 3 (1) E % Acute Aq Tox Cat. 1 (50) Bioaccumulation (50) 4 F 5-9.9% No Data Available (75) 5 44 G % Acute Aq Tox Cat. 3 (10) VOC(50) Hazardous Air Pollutants (40) F 5-9.9% No Data Available (75) HEA = 200 Substance (50) Chronic Target Organ Tox (50) TOTAL = 525 Corrosive to Metals (1) Acute Toxicity Cat. 4 (1) Corrosivity Cat. 1 (5) Acute Target Organ Tox (10) Acute Toxicity Cat. 4 (5) Oxidizing Liquid (25) Corrosivity Cat. 1 (10) Acute Target Organ Tox (25) No Data Available (25) Flammable Liquid Cat. 2 (25) No Data Available (25) *Remaining % is water (CSI score 0) Corrosivity Cat. 1 (5) Reproductive Tox (50) Acute Tox Cat. 3 (25) Corrosivity Cat. 2 (5) Acute Target Organ Tox (25) Chronic Target Organ Tox (25) Corrosivity Cat. 1 (5) ENV = 101 PHY = 26 HEA = 56 TOTAL = 183 ENV = 75 PHY = 25 HEA = 5 TOTAL = 105 ENV = 175 PHY = 50 HEA = 135 TOTAL = 360

45 CSI Product Scoring Example *Product contains components that lack hazard data 45

46 CSI Conclusion CSI scores and ranks comparable products based on intrinsic HSE hazards of their chemical components Relative ranking of "most hazardous" versus "least hazardous" products Easily amenable to use by other types of industries and/or other stakeholders Could be implemented more broadly to provide an industry-wide standard for product safety evaluations 46

47 Leverage Your GHS Data For Product substitution/alternative assessment Prioritize data gathering Product portfolio review Communication tool (internally/externally) 47

48 Questions? Tim Verslycke Gradient Cambridge, MA, USA 48

49 Emerging Green Chemistry Regulatory Initiatives (and how to meet them) Tom Lewandowski, Ph.D., DABT Gradient, Seattle WA January 15, 2015

50 Moving from Hazard Scoring to Assessing Alternatives Once chemical hazards in a product are identified, what can you do? Alternatives Assessments guide the evaluation of possible less hazardous substitutes Goal: a comprehensive understanding of the potential effects of any change in product composition across multiple categories Big challenge for products with complex and/or multinational supply chains Emphasis on the whole product lifecycle Method for weighing one hazard versus another is a key issue Concerns to address, for the chemical and its precursors and products: Human health effects Ecotoxicity Ecological effects (e.g., acid rain) Exposure potential Flammability/Explosiveness Ozone depletion Global warming potential Technical feasibility Performance Cost Societal impacts 50

51 Life Cycle Assessment Alternatives Assessment requires consideration of life cycle Key life cycle questions How finely do we need to analyze the issue (e.g., how many layers? consider every single component no matter how minor?) Where will the data about inputs and outputs for each stage of the product life cycle come from? Quantify the potential environmental impacts of those inputs and outputs Interpretation Place into context, discuss uncertainties, etc. Raw Materials Product Raw Materials Low concern <0.1% <0.1% Product 51

52 Example: Watch Bands Current product is a polyurethane based material Pros and Cons of the current formulation Flexible material, easily colored/textured Well established chemistry, easily modified d to address new product lines Production of base material involves diisocyanates, some of which are known sensitizers and also phosgene, a hazardous gas Based stock is fossil fuel-based Possible alternatives leather, other plastics, metal, silicones 52

53 Example: Watch Bands (2) Compare impacts of these alternatives across raw material acquisition, product production, product use, product end of life How do the greenhouse gas emissions of producing leather compare to steel? Is allergy to leather dye as common as allergy to diisocyanates? What do consumers want and can these materials satisfy those needs? What about end of life? Leather is compostable (but is it?), silicone rubber is not easily recycled 53

54 Regulatory Drivers

55 Green Chemistry Regulatory Activity in 2014 States That Considered Toxic Chemicals Legislation in 2014 Already have alternative analysis requirement 55 Source: Considering legislation requiring alternatives assessment or use of least toxic substitute for proposed bans

56 California Safer Consumer Products Regulations "a sea change in the way that California is going to be managing toxic chemicals" (LA Times, 9/26/13) CalEPA/DTSC establishes candidate chemicals Currently ~1200 chemicals listed as "of concern" by various groups CA EPA/DTSC identifies priority products containing those chemicals which have the potential to pose "significant or widespread adverse impacts" Identified priority products are the focus of regulation Priority products requiring alternatives analyses or regulatory responses 56

57 SCP Priority Products 1 st priority products proposed March 13, 2014 Polyurethane spray foams containing unreacted isocyanates, Paint and varnish strippers containing methylene chloride, Children's foam sleeping products containing the flame retardant TDCCP Formal rulemaking process complete by late 2015 (?) Draft work plan outlining i future product categories published in October 2014 EZ Paint Stripper 57

58 Future Product Categories Seven future target product categories identified 1. Beauty, personal care, and hygiene products 2. Certain building products (adhesives, sealants, and flooring) 3. Cleaning products 4. Clothing products 5. Fishing and angling equipment 6. Consumable elements of office equipment (e.g., inks, toners) 7. Household and office furnishings treated with flame retardants and stain repellants Expectation is that DTSC will choose 5 to 10 products per year from these categories starting in

59 Required Responses Remove the chemical from the product, stop selling the product in CA, or submit an alternatives assessment to CA DTSC Not permissible to simply substitute another chemical Conducting Alternatives Assessment under SCP Cost for alternatives assessment is unclear but could be at least several $100K Key factors: availability of data, the complexity of the product, other regulatory requirements Suppliers will be reluctant to provide information for comparing alternative formulations Antitrust concerns for trade associations or other industry groups Copies of all AAs will be posted on the DTSC website for public comment Compliance timeframe is as short as years 59

60 Other States Washington s Children s Safe Products Act 65 chemicals Manufacturers of products containing these chemicals must state presence, quantity, & function Threshold is the practical quantitation limit (PQL) Information is posted on a public website Alternative Assessment requirement has been proposed Maine Toxic Chemicals in Children's Products Act Requires notification of presence and possible alternatives assessment Vermont Similar to Washington law Covers consumer products rather than children s products Opening for alternatives assessment in later years 60

61 European Union - REACH Substances of very high concern are nominated to Annex XIV CMR, PBT, vpvb Manufacturers, importers, or users must apply for authorization to use these substances Authorization application requires consideration of potential alternatives Must consider the risks, availability, the technical and economic feasibility If alternatives are identified a substitution plan and time table must be developed No clear guidance yet, under development 61

62 AA Tools

63 Different Methods for Conducting AAs Framework Metric of Interest California i SCP Regulation IC2 AA Guidance EPA DfE Guidance German UNEP REACH Guide on General Authorization Sustainable Guidance on Analysis of Chemicals Alternatives Alternatives Lowell Center AA Framework Product Function Useful Life Materials Usage?? Water Usage Water Quality Impact partial partial partial Air Emissions partial partial partial Prod. Use Energy Inputs partial Energy Efficiency Emissions? Waste, End of Life Issues partial Public Health Impacts partial partial partial partial Environmental Impacts partial partial partial partial partial partial Economic Impacts partial partial partial partial 63

64 Example: IC2 Guidance on Alternative Assessment A consortium of 10 states developed basic alternatives assessment guidance California, Connecticut, Maine, Massachusetts, Michigan, Minnesota, New York, Oregon, Vermont, and Washington Idea is to save regulatory efforts, enhance consistency Different modules used to complete different elements of the assessment process (performance, hazard, cost/availability, exposure, materials management, social impact and life cycle thinking) Allows for flexibility in selecting/implementing gmodules Simultaneous/Sequential/Hybrid Decision Frameworks Both a benefit and a serious problem Different interpretations/decisions = different results? How to evaluate alternatives within each module is not entirely clear Is a mutagen worse than a reproductive toxicant or worse than a chemical with high aquatic toxicity? 64

65 IC2 Sequential Decision Framework 65 Easy to describe and carry out, may result in premature dropping of alternatives

66 IC2 Simultaneous Decision Framework Requires weighting formula for modules, potentially arbitrary, less likelihood of early alternative elimination 66

67 IC2 Hybrid Decision Framework 67 Less likelihood of early alternative elimination but still somewhat arbitrary

68 NRC Chemical AA Guidance (Oct., 2014) Stepwise framework for completing an AA Not a lot about methods Key difference is placing of exposure and hazard on an equal footing Doesn t mean a return to risk Risk and exposure are not combined Low exposure is not a reason to avoid seeking alternatives An alternative that improves on exposure potential is also worthwhile Not clear yet if this will be a priority approach 68

69 Summary Increasing interest in green chemistry/green products places focus on chemical hazard rather than risk Due to public pressure and interest in decreasing product liability The relative importance of hazard vs. risk is still being debated Expect more regulatory requirements for alternative assessment Expect additional states to adopt chemical reporting regulations that require alternative consideration Expect consolidation in tools and approaches (NRC framework?) Expect more specificity as to what is required 69

70 Thank You! Kim Reid Gradient 20 University Road Cambridge, MA Tom Lewandowski Gradient 600 Stewart Street Seattle, WA Tim Verslycke Gradient 20 University Road Cambridge, MA