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Department of Toxic Substances Control Cal/EPA Draft Alternatives Analysis Guide Webinar January 10, 2017

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  • Department of Toxic Substances Control Cal/EPA

    Draft Alternatives Analysis Guide Webinar

    January 10, 2017

  • About the Webinar

    Overview of the SCP regulations AA process Introduce contents of the Guide

    2

  • Safer Consumer Products Framework 22 CCR Sections 69501-69510

    As designated by 23 authoritative bodies

    Product-Chemical combinations that may cause harm

    Manufacturer evaluation of alternatives

    DTSC considers range of possible responses 3

    Article 5 Section 69505

  • Alternatives Analysis Process

    4

  • Timeline of Report Submission

    5

    180 days 60 days 12 months 60 days

    • Preliminary AA Report • Abridged AA Report

    Priority Product

    Notification

    DTSC review

    Notice of Compliance or

    Notice of Deficiency

    Final AA Report Final Priority

    Product List

  • Comment at https://calsafer.dtsc.ca.gov/Comments/PackageDetail.aspx?PID=11811

    6

  • About the Guide…

    7

  • SCP AA Framework

    List of factors to be considered Economic impacts

    Mandatory life cycle consideration

    Not limited to chemical substitution

    No requirement to generate new data

    8

  • About the Guide...

    9

    The Guide IS: The Guide IS NOT:

    Guidance Regulations

    Dynamic Static

    A menu of options Step-by-step instructions

  • Guide and AA Steps

    Step 3: Identification of Relevant Factors

    Step 1: Identification of Relevant Factors

    Chapter

    3

    Chapter

    3

  • Guide Content: First Stage

    – AA Framework – Product Requirements and Alternatives – Relevant Factors – Impact Assessments – Screening of Alternatives

    11

    First Stage AA is screening analysis

    Chapter 1

    Chapter 4

    Chapter 2

    Chapter 3

    Chapter 5

  • First Stage AA

    Chapter 1 – AA Framework • Two-Stage Process • Options • Appendix 1: Summary of Required Information for AA

    Reports

    Chapter 2 – Product Requirements and Alternatives

    • Function, Performance, Legal • Identification of Alternatives

    12

  • First Stage AA Chapter 3 – Relevant Factors

    • Factors for comparison • A factor is relevant if:

    – Factor makes material contribution to impacts – There is material difference in factor’s contribution

    13

  • Factors to Consider for Relevance:

    Adverse environmental impacts

    Adverse public health impacts

    Adverse waste and end-of-life effects

    Materials and resource consumption impacts

    Physical chemical hazards

    Exposure pathways

    Life cycle segments

    14

  • Relevant factors are nested: Appendix 3-1

    15

    Factor Subcategory

    Adverse Environmental

    Impacts

    Factors

    Adverse Air Quality Impacts

    on aquatic and terrestrial ecosystems

    on aquatic, avian or terrestrial animal, plant organisms, or microbes

    …….

    ……………..

    ………

    Adverse Ecological Impacts

    Adverse Soil Quality ImpactsAdverse Water Quality Impacts

    Carbon dioxideHydrofluorocarbonsMethaneNitrogen trifluorideNitrous oxidePerfluorocarbonsSulfur hexafluorideOther global warming potential gases

    Stratospheric ozone depletion substancesSulfur oxidesTropospheric ozone forming compounds

    SubfactorsCalifornia Toxic Air Contaminants

    Greenhouse Gases

    Nitrogen oxidesParticulate Matter

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

    Sheet1

    Factor SubcategoryFactorsSubfactors

    Adverse Environmental ImpactsAdverse Air Quality ImpactsCalifornia Toxic Air Contaminants

    Greenhouse GasesCarbon dioxide

    Hydrofluorocarbons

    Methane

    Nitrogen trifluoride

    Nitrous oxide

    Perfluorocarbons

    Sulfur hexafluoride

    Other global warming potential gases

    Nitrogen oxides

    Particulate Matter

    Stratospheric ozone depletion substances

    Sulfur oxides

    Tropospheric ozone forming compounds

    Adverse Ecological Impactson aquatic, avian or terrestrial animal, plant organisms, or microbes

    on aquatic and terrestrial ecosystems

    Adverse Soil Quality Impacts…….

    ………

    Adverse Water Quality Impacts……..

    ………

    Sheet2

    Sheet3

  • First Stage AA

    Chapter 4 – Impact Assessments • Chemical Hazard Assessment

    Chapter 5 – Screening of Alternatives

    16

    Preliminary AA Report describes screening results and Work Plan

  • Guide Content: Second Stage – Exposure – Life Cycle Impacts – Economic Impacts – Information Needs in AA – Selection of Alternatives – Self-Evaluation of AA

    17

    Second Stage AA In-Depth Analysis

    Chapter 6 Chapter 7

    Chapter 11

    Chapter 8 Chapter 9 Chapter 10

  • Chapter 6 — Exposure

    18

    Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

    Step 3: Consideration of Additional Information

    Step 4: Alternatives Selection Decision

    Step 5: Final AA Report

    Second Stage AA In-Depth Analysis

    Chapter

    6 Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

    Step 3: Consideration of Additional Information

    Step 4: Alternatives Selection Decision

    Step 5: Final AA Report

    Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

  • Exposure Assessment Considerations

    Chemical quantity

    Exposures to the hazardous chemical in the product

    Household and workplace presence of the product

    Exposures during the product’s life cycle

    19

  • Methods for Potential Exposure Evaluation

    Exposure Assessment Models Conceptual Model

    • Graphical representation of exposure source and receptors • Identify exposure pathways

    – Fate and transport – Exposure routes – Potential receptors

    20

  • Conceptual Model – Exposure Pathways

    21

  • Chapter 7 — Life Cycle Impacts

    22

    Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

    Step 3: Consideration of Additional Information

    Step 4: Alternatives Selection Decision

    Step 5: Final AA Report

    Second Stage AA In-Depth Analysis

    Chapter

    7 Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

  • Chapter 7 — Life Cycle Impacts

    Life Cycle Thinking • Consider full life cycle

    LCA Tools

    ISO-compliant LCA not required

    23

  • Sample Matrix for Evaluation of Alternatives at Various Life Cycle Stages

    24

    Raw

    Mat

    eria

    l

    Extr

    actio

    nIn

    term

    edia

    te

    Mat

    eria

    ls P

    roce

    sses

    Man

    ufac

    ture

    Use

    End-

    of-li

    fe D

    ispo

    sal

    Impact: Human HealthPriority Product L H H H HAlternative A H H M L LAlternative B L M M MImpact: Air QualityPriority Product H M L L LAlternative A H H M L LAlternative B H H H HImpact: Water QualityPriority Product H M L L HAlternative A H M M L LAlternative B H H L M

    Sheet1

    Matrix for Simplified Evaluation of Alternatives at Various Life Cycle Stages

    Raw Material ExtractionIntermediate Materials ProcessesManufactureUseEnd-of-life Disposal

    Impact: Human Health

    Priority ProductLHHHH

    Alternative AHHMLL

    Alternative BLMMM

    Impact: Air Quality

    Priority ProductHMLLL

    Alternative AHHMLL

    Alternative BHHHH

    Impact: Water Quality

    Priority ProductHMLLH

    Alternative AHMMLL

    Alternative BHHLM

  • Chapter 8 — Economic Impacts

    25

    Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

    Step 3: Consideration of Additional Information

    Step 4: Alternatives Selection Decision

    Step 5: Final AA Report

    Second Stage AA In-Depth Analysis

    Chapter

    8 Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

  • Chapter 8 — Economic Impacts

    Internal Costs External Costs

    • public health and environmental costs • costs to governmental agencies and non-profit

    organizations

    Not about absolute value of costs

    Approaches Presented – with Flexibility

    26

  • Examples of Costs

    Morbidity and mortality Costs

    Cost of emissions

    Ecosystem services

    27

  • Chapter 9 — Informational Needs in AA

    28

  • Informational Needs

    Addressing Manufacturing Process-Specific Data Gaps • Proxy Data • Extrapolated Data

    Addressing Chemical-specific Data Gaps • Read-across • Quantitative Structure-Activity Relationship model

    Addressing Uncertainty • Qualitative • Quantitative

    29

  • Chapter 10 — Selection of Alternatives

    30

    Step 1: Identification of Relevant Factors

    Step 2: Comparison of the Priority Products & Alternatives

    Step 3: Consideration of Additional Information

    Step 4: Alternatives Selection Decision

    Step 5: Final AA Report

    Second Stage AA In-Depth Analysis

    Chapter

    10 Step 4: Alternatives Selection Decision

  • Chapter 10 — Selection of Alternatives

    Sequential Framework Simultaneous Framework

    Hybrid

    31

  • Sequential Framework

    32

    Adapted From: Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guide

  • Simultaneous Approach

    33

    Adapted From: Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guide

  • Hybrid Framework

    34

    Adapted From: Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guide

  • Chapter 11 — Self Evaluation of AA

    35

  • AA Report Evaluation

    Comprehensive • Appendix 1 – Summary of Required Information for AA

    Reports • Comparison of alternatives • Relevant factors • Selected alternative and implementation

    Reasonable

    • Based on reliable information • Valid • Plausible: Adequate analysis 36

  • Summary

    Menu of Approaches Flexible Well-Documented: Show your work! Consult the Regulations

    37

  • DTSC wants your feedback

    Comments through CalSAFER by February 3, 2017

    38

  • Next Steps

    Green Ribbon Science Panel discussion - Early Spring 2017 Finalize Guide - Late Spring 2017

    39

  • Thank You!

    40

    Slide Number 1About the WebinarSafer Consumer Products Framework�22 CCR Sections 69501-69510Alternatives Analysis ProcessTimeline of Report SubmissionComment at https://calsafer.dtsc.ca.gov/Comments/PackageDetail.aspx?PID=11811About the Guide…SCP AA FrameworkAbout the Guide...Guide and AA StepsGuide Content: First StageFirst Stage AAFirst Stage AAFactors to Consider for Relevance:Relevant factors are nested: Appendix 3-1First Stage AAGuide Content: Second StageChapter 6 — ExposureExposure Assessment ConsiderationsMethods for Potential Exposure EvaluationConceptual Model – Exposure PathwaysChapter 7 — Life Cycle Impacts Chapter 7 — Life Cycle Impacts Sample Matrix for Evaluation of Alternatives at Various Life Cycle StagesChapter 8 — Economic ImpactsChapter 8 — Economic ImpactsExamples of CostsChapter 9 — Informational Needs in AAInformational NeedsChapter 10 — Selection of Alternatives Chapter 10 — Selection of Alternatives Sequential FrameworkSimultaneous ApproachHybrid FrameworkChapter 11 — Self Evaluation of AAAA Report EvaluationSummaryDTSC wants your feedback�Next StepsSlide Number 40