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
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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
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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
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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
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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
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Second Stage AA In-Depth Analysis
Chapter 6 Chapter 7
Chapter 11
Chapter 8 Chapter 9 Chapter 10
Chapter 6 — Exposure
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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
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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
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Conceptual Model – Exposure Pathways
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Chapter 7 — Life Cycle Impacts
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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
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Sample Matrix for Evaluation of Alternatives at Various Life Cycle Stages
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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
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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
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Examples of Costs
Morbidity and mortality Costs
Cost of emissions
Ecosystem services
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Chapter 9 — Informational Needs in AA
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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
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Chapter 10 — Selection of Alternatives
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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
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Sequential Framework
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Adapted From: Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guide
Simultaneous Approach
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Adapted From: Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guide
Hybrid Framework
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Adapted From: Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guide
Chapter 11 — Self Evaluation of AA
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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
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DTSC wants your feedback
Comments through CalSAFER by February 3, 2017
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Next Steps
Green Ribbon Science Panel discussion - Early Spring 2017 Finalize Guide - Late Spring 2017
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Thank You!
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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
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