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Department of Toxic Substances Control CalEPA
Alternatives Analysis: What You Need to Know
DTSC Alternatives Analysis Workshop
February 7, 2019
Department of Toxic Substances Control CalEPA
Introduction to Safer Consumer Products Alternatives Analysis (AA)
Suzanne Davis, Senior Hazardous Substances EngineerSafer Products and Workplaces Program
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Please note: The contents of this workshop does not alter or determine compliance responsibilities set forth in statutory and regulatory requirements.
Topic Presenter
Priority Product Reporting Requirements Diana
Alternatives Analysis (AA) Process
Stage 1 AA Xiaoying
Stage 2 AA Heather
Reporting Options Melissa
Extensions Melissa
Trade Secret Information Lynn G.
Resources Kelly
Questions and Answers AA Team and OLC
Closing Statement Karl
Workshop Agenda
Safer Consumer Products framework
As designated by 23 authoritative bodies
DTSC selects Product-Chemical combinations that may cause harm
Manufacturer evaluation of alternatives
DTSC considers range of possible responses
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Division 4.5, Title 22, California Code of Regulations, Chapter 55 Safer Consumer Products
Alternatives Analysis Process
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Alternatives Analysis vs. Alternatives Assessment
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Alternatives Assessment
Alternatives Analysis
SCP AA versus Alternatives AssessmentTopic Area Alternatives Analysis Alternatives Assessment
Performance Yes Yes
Function Yes Yes
Legal Requirements Yes Varies
Identification of Alternatives Yes Yes
Identification of Relevant Factors Yes Not discussed
Hazard Traits Yes Varies
Exposure Yes Varies
Initial Screening Yes Yes
Life Cycle Impacts Yes Varies
Economic Impacts Yes Varies
Decision-making Yes Varies
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Department of Toxic Substances Control CalEPA
Priority Product Notifications
Diana Phelps, PhD, Hazardous Substances EngineerSafer Products and Workplaces Program
Priority Product Notifications (PPN)
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Manufacturers for Priority Product:
Shall notify DTSC within 60 days of the Priority Product regulation effective date, e.g. Paint or Varnish Strippers with Methylene Chloride (March 4th, 2019).
PPN must include:
• Contact and statement indicating if manufacturer, importer, assembler, or retailer
• Type, brand name (s) and the product name (s)– Description of product; component of one or more assembled
product?
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How to Submit Priority Product Notifications (PPN) https://calsafer.dtsc.ca.gov
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Submit Icon
Steps to submit PPN Information in CalSafer:
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Responsible Entity Step
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Priority Product Step
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Product Information Step
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Review Step (1/2)
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Review Step (2/2)
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Certify & Submit 1/2
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Certify & Submit 2/2
After PPN submittal:
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Department of Toxic Substances Control CalEPA
Alternatives Analysis: First Stage
Xiaoying Zhou, P.E., PhD, Senior Hazardous Substances EngineerSafer Products and Workplaces Program
First-Stage Alternatives Analysis
Final AA ReportTimeline
Preliminary AA Report
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First Stage Alternatives Analysis
Key Concepts• Is it necessary• Identify possible viable
alternatives• Life cycle thinking• Scoping and screening
analysis
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Factors to be considered in first stage AA
• Adverse environmental impacts
• Adverse public health impacts
• Adverse waste and end-of-life effects
• Environmental fate
• Materials and resource consumption impacts
• Physical chemical hazards
• Physicochemical properties
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Division 4.5, Title 22, California Code of Regulations Chapter 54 Green Chemistry Hazard Traits, Toxicological and Environmental Endpoints and Other Relevant Data
Adverse Environmental Impacts
Adverse Public Health Impacts
Adverse Waste and End-of-life Effects
Environmental Fate
Materials and Resource Consumption
Physical Chemical Hazards
Physicochemical Properties
From AA Guide p170
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Factors to be considered (Cont.)
Resources for First Stage AA
AA Guide (Version 1.0, June 2017)
https://dtsc.ca.gov/SCP/AlternativesAnalysisGuidance.cfm
• Chapter 1 – AA Framework• Chapter 2 – Product Requirements and
Alternatives• Chapter 3 – Relevant Factors• Chapter 4 – Impact Assessments• Chapter 5 – Screening of Alternatives• Appendix 1 - Required Information for
AA Reports
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Resources (Cont.)
Preliminary AA Report Template released on June 2018
Optional to use
Requirements for AA Reports (CCR section 69505.7)
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https://dtsc.ca.gov/SCP/Preliminary_AA_Report_Template.cfm
Resources (Cont.)
Alternatives Assessment examples review• Product requirement• Identification of alternatives• Identification of relevant factors• Initial screening
https://dtsc.ca.gov/SCP/Alternatives_Assessment_Examples.cfm29
Resources (Cont.)
CalSAFER, the central web portal to submit AA URL Link: https://calsafer.dtsc.ca.gov/ Training module is coming soon
https://calsafer.dtsc.ca.gov/workflows/PreliminaryAAReport/
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Department of Toxic Substances Control CalEPA
Alternatives Analysis: Second Stage
Heather Lee, P.E., Senior Hazardous Substances EngineerSafer Products and Workplaces Program
Two Stage Alternatives Analysis (AA)
Final AA Report
Preliminary AA Report
First Stage AA
Second Stage AA
Resources:California Code of Regulations, title 22, section 69505.6 Alternatives Analysis: Second Stage
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Timeline of Report Submission
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Second Stage Alternatives Analysis
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Key Concepts• In-depth comparative
analysis of the alternatives selected in the 1st Stage AA
• What alternatives are safer and feasible?
• Alternative selection decision
Second Stage: In-depth Analysis
1. Factors to be considered in the 2nd Stage AA:
Adverse environmental impactsAdverse public health impactsAdverse waste and end-of-life effectsEnvironmental fateMaterials and resource consumption impactsPhysical chemical hazardsPhysicochemical properties
Product function and performance Economic impacts
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Division 4.5, Title 22, California Code of Regulations Chapter 54 Green Chemistry Hazard Traits, Toxicological and Environmental Endpoints and Other Relevant Data
1stSt
age
2ndSt
age
Tip:Identify relevant factors
Material contribution Material difference
AA Guide:Chapter 3 - Relevant Factors
Product Function and Performance
Manufacturer-intended use, function and performance attributes, and legal requirements and evaluate:• Useful life of the product and alternatives• Function and performance of each alternative • Whether an alternative exists that is functionally acceptable,
technically feasible, and economically feasible
AA Guide:Chapter 2 - Product Requirements
and Alternatives
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Economic Impacts (Internal and External)
Evaluate, monetize, and compare the following impacts of the PP and alternatives:• Public health and environmental costs• Costs to impacted governmental agencies and non-profit organizations.
AA Guide:Chapter 8 - Economic Impacts
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2. Comparison of Priority Product and Alternatives Compare the PP and each alternative with respect to each
identified relevant factor and associated exposure pathways and life cycle segment.
For each alternative, compare it with respect to the PP and each of the other alternatives
AA Guide:Chapter 4 - Impact AssessmentsChapter 5 - Screening of Alternatives
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Tips:• Use available information and
analytical tools• Comparative analysis• Use the same relevant factors
for comparison• Show your work
3. Consideration of Additional Information (optional) You may consider other relevant information not identified in
the previous steps. This may include (but is not limited to) reconsideration of the
factors and information that were identified in the 1st Stage AA.
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4. Alternative Selection Decision
Select the alternative that will replace the PP (unless the decision is to retain the PP).
Support your decision with the comparative analysis
AA Guide:Chapter 10 - Selection of Alternatives
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5. Final AA Report
Submit a Final AA Report that contains your analysis Specific reporting requirements are in the regulations under
Section 69505.7 Alternatives Analysis Reports. CalSAFER, Web portal to submit AA Reports URL Link: https://calsafer.dtsc.ca.gov/
AA Guide:Appendix 1 - Required Information for AA Reports
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Department of Toxic Substances Control Cal/EPA
Options to AA Reports
Melissa Salinas, Hazardous Substances EngineerSafer Products and Workplaces Program
Options to AA Reports
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Abridged AA
After the first 5 steps of First Stage AA
No functionally acceptable and technically feasible alternatives
Keep the Priority Product
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Abridged AA
Requires summary of findings from First Stage AA and portions of the Second Stage AA
Due date – 180 days from the date the Priority Product Regulations become effective
Expedite the process toward research and development
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Alternate Process AA
AA process different than two-stage AA process
Alternate Process Work Plan required
• Demonstrate the Alternate Process AA fulfills the requirements of the two-stage AA process
• Work Plan due date – within 60 days of the effective date of the Priority Product regulations
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Alternate Process AA
Alternate Process AA must provided information needed to prepare a Final AA Report
Final AA Report due date – 18 months after the notice of compliance for the Work Plan
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Previously Completed AA
Conducted AA or publicly available AA
Report must be substantially equivalent to the Final AA Report requirements
AA can be supplemented
Due date - 180 days from the date the Priority Product Regulations become effective
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Removal/Replacement Notifications
Chemical Removal - remove the Chemical of Concern from the Priority Product
Product-Chemical Replacement - replace the Chemical of Concern in the Priority Product
Product Removal - remove the Priority Product from sale in California
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Removal/Replacement Notifications
Intent Notifications • Due date – 180 days from the date the Priority Product
Regulations become effective
Confirmation Notifications• Due date – within 90 days of Intent Notification submittal
SCP Regulations, Section 69505.2
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Consortium Option
Reporting by Consortium• Consortium, trade association, public-private partnership,
non-profit organization, or other entity
https://calsafer.dtsc.ca.gov/51
Department of Toxic Substances Control Cal/EPA
AA Extensions
Melissa Salinas, Hazardous Substances EngineerSafer Products and Workplaces Program
AA Extensions
One-time extension up to 90 days• Preliminary AA Report• Alternate Process Work Plan• Previously Completed AA Report
Must be received 60 days before report due date
Must be based on unforeseeable circumstances53
AA Extensions
Abridged AA Report• Eligible for a one-time extension up to 90 days, after a
notice of deficiency
Final AA Report • Must not exceed 24 months from the Preliminary AA
Report Notice of Compliance
https://calsafer.dtsc.ca.gov/ 54
Department of Toxic Substances Control CalEPA
SCP Trade Secret Information
Lynn Goldman, Senior Attorney Office of Legal Counsel
Submittal of Trade Secret Information Process outlined in the SCP regulations, Article 9 (CCR 69509)
DTSC requires a redacted and unredacted version of any information submitted with a claim of trade secret protection
Submittal must include the substantiating information identified in the regulations to support the claim
DTSC will not disclose information submitted with a claim of trade secret protection without reviewing the claim• If DTSC finds the claim is not sufficiently supported, DTSC will give
notice to submitter and allow additional time to support claim
• If claim remains unsupported, DTSC will give the submitter 30-days notice before disclosing the information, during which time the submitter may seek judicial review
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Department of Toxic Substances Control Cal/EPA
Resourceshttps://www.dtsc.ca.gov/SCP/AlternativesAnalysis.cfm
Kelly Grant, PhD, Environmental ScientistSafer Products and Workplaces Program
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Alternatives Analysis Resources
Preliminary AA Template
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AA Guide
AA Guide
Function of the product and the chemical Tools to research potential impacts How to identify relevant factors Tools for:
• Qualitative or comparative exposure assessment• Investigate impacts across the product life cycle• Economic analysis
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Alternatives Analysis Resources
Alternatives Analysis Resources
Links to webinars on: 2-days of Alternatives Analysis, Life Cycle Impacts, &
Exposure Assessment• https://www.youtube.com/watch?v=hEz2pCgI8Wo&feature
=youtu.be• https://www.youtube.com/watch?v=n-
kIO4Txtcc&feature=youtu.be Monetizing impacts to public health
• https://www.youtube.com/watch?v=oA8Ng1tIthQ&feature=youtu.be
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Alternatives Analysis Resources
Fact Sheets on: Introduction to the Alternatives Analysis Process
https://www.dtsc.ca.gov/SCP/upload/Intro_to_AA_Process.pdf
Alternatives Analysis Reporting Options https://www.dtsc.ca.gov/SCP/upload/AA-Reporting-Options.pdf
Notifications in lieu of Alternatives Analysis https://www.dtsc.ca.gov/SCP/upload/Notifications_in_Lieu.pdf
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Alternatives Assessment Examples
Alternatives Assessment Examples
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Lessons Learned from Alternatives Assessment Examples
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SCP Email Sign-up
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Compendium of Helpful Links AA Regs (Article 5 § 69505.4-.7):
https://dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Final-Regs-Text-10-01-2013.pdf
AA Homepage: https://www.dtsc.ca.gov/SCP/AlternativesAnalysis.cfm AA Guide: https://www.dtsc.ca.gov/SCP/AA-Guide-Survey.cfm Alternatives Assessment Examples:
https://www.dtsc.ca.gov/SCP/Alternatives_Assessment_Examples.cfm Preliminary AA template:
https://www.dtsc.ca.gov/SCP/AlternativesAnalysisResources.cfm Webinars on the preparation of an AA:
https://www.youtube.com/watch?v=hEz2pCgI8Wo&feature=youtu.behttps://www.youtube.com/watch?v=n-kIO4Txtcc&feature=youtu.behttps://www.youtube.com/watch?v=oA8Ng1tIthQ&feature=youtu.be
Factsheets on AA and Reporting Options: https://www.dtsc.ca.gov/SCP/upload/Intro_to_AA_Process.pdfhttps://www.dtsc.ca.gov/SCP/upload/AA-Reporting-Options.pdfhttps://www.dtsc.ca.gov/SCP/upload/Notifications_in_Lieu.pdf 69
Any Questions or Comments?Please contact us via
Thank you!
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