CEPA: Assessing and Managing Risks of Existing Chemicals in Canada

1. ComET Peer Input Meeting Context & ObjectivesNov. 8th, 2004Bette Meek, Health Canadawww.hc-sc.gc.ca/exsd-dse

2. Who Are We? • Existing Substances Division of the Healthy Environments & Consumer Safety Branch of Health Canada (HECS/HC) • Address HC responsibilities for Existing Industrial Chemicals under the Canadian Environmental Protection Act (CEPA) • Partnership with Environment Canada • Administrators of CEPA • What does this mean…………………..???? ComET Peer Input meeting, Cincinnati, Nov. 8th/04

3. The Canadian Environmental Protection Act (CEPA) • To protect the environment, human life and health from risks associated with pollution • Primary authority to assess and manage the risks posed by toxic substances (not covered under other legislation) to protect health and the environment • Risk assessment the scientific underpinning • Progressive, encompassing with broad range of powers for (e.g.): • information gathering & reporting/research • assessment and management/control • Enforcement/Emergency planning • Administered by Environment Canada and Health Canada • Introduced in 1988 and renewed in 1999 • Provision for renewal every 5 years ComET Peer Input meeting, Cincinnati, Nov. 8th/04

4. What is “CEPA toxic”? Outcome of Risk Assessment • A substance is “CEPA toxic” when it enters or may enter the environment in a quantity or under conditions that: • “have or may have an immediate or long-term harmful effect on the environment or its biological diversity” – subsection 64(a) • “constitute or may constitute a danger to the environment on which life depends” – subsection 64(b) • “constitute or may constitute a danger in Canada to human life or health” – subsection 64(c) ComET Peer Input meeting, Cincinnati, Nov. 8th/04

5. Mandated Timeframes in CEPA Drivers Risk Assessment Research & Surveillance Public CEPA Registry Risk Management Program Management Mandated CEPA time-frames ComET Peer Input meeting, Cincinnati, Nov. 8th/04

6. Existing Substances under CEPA • Approximately 23,000 substances (e.g., industrial chemicals) on the Domestic Substances List (DSL) • The DSL was created for the purpose of defining a “new substance” under CEPA • If “notified” at time of compilation, not considered “new” • Includes substances “grandfathered” under the legislation • i.e., those used for commercial manufacturing or manufactured or imported in Canada at • >100 kg/year between January 1, 1984 and December 31, 1986 • Organics (50%), inorganics, polymers and substances of unknown or variable composition, complex reaction products & biological materials (UVCBs) 2 ComET Peer Input meeting, Cincinnati, Nov. 8th/04

7. Assessment of CEPA Existing Substances – Health Canada Mandate • Address both exposure and effect to set priorities for risk management • Consumer & Environmental Exposure • All age groups • Multimedia • Identifying most important media/sources of human exposure • Source characterizations to inform risk management • Information Gathering/Industrial Surveys • Publicly accountable – transparent process, peer review, documented outcome • Information gathering, reverse onus provisions, but responsibility of Government considerable ComET Peer Input meeting, Cincinnati, Nov. 8th/04

8. CEPA – Why Consumer Exposure? • CEPA is progressive, requiring systematic consideration of multimedia exposure to existing chemicals • Broad range of powers under CEPA for risk management of substances • HECS has responsibility for both the Hazardous Products Act & CEPA – health aspects ComET Peer Input meeting, Cincinnati, Nov. 8th/04

9. Assessment of CEPA Existing Substances • Under CEPA ’88, assessments focussed on limited numbers of Priority Substances (5 yr mandated timeframe) • N= 44 on Priority Substance List 1 (completed 1994) • N= 25 on Priority Substance List 2 (completed 2000) • CEPA ’99 extended our mandate to all Existing Substances in Canada (n=23,000) • “Categorization” by 2006 to set priorities for “screening” & full (Priority Substances) assessment • Mandate is leading, internationally ComET Peer Input meeting, Cincinnati, Nov. 8th/04

10. CEPA Existing Substances Program CATEGORIZATION of the Domestic Substances List (DSL) (First Phase) (n=23,000) Decisions of Other Jurisdictions Public Nominations STAGE 1 STAGE 2 Greatest Potential for Human Exposure Substances that are Persistent or Bioaccumulative “Inherently Toxic” to Humans “Inherently Toxic” to non-Human Organisms STAGE 3 SCREENING ASSESSMENT (Second Phase) No further action under this program Risk Management CEPA-Toxic IN-DEPTH ASSESSMENT - Priority Substances List (Third Phase) No further action under this program Risk Management CEPA-Toxic STAGE N-1 STAGE N ComET Peer Input meeting, Cincinnati, Nov. 8th/04

11. “Categorization” (Priority Setting) for Existing Substances • Short Term Objective: • To systematically set priorities for data generation and assessment for both human health and ecological effects of all Existing Substances, without bias • Long Term Objective: • Greater consistency in consideration of New versus Existing Substances • Why is this Important? • Many, if not most Existing Substances pose greater risk than New Substances • Widespread use, often higher toxicity • Not systematically considered ComET Peer Input meeting, Cincinnati, Nov. 8th/04

12. Principles of “Categorization” of Existing Substances (Cont’d) • Requires significant technical capacity to “develop”/ “force” the science for precedent setting mandate • Expanding previous work on exposure/predictive hazard tools • Drawing upon relevant resources internationally • E.g., collaboration with European Commission/European industry • Cut for “categorization” to be determined by the deadline(2006) & informed by: • public debate • iterative stages of “sorting” to identify priorities • Simple and complex tools ComET Peer Input meeting, Cincinnati, Nov. 8th/04

13. Principles/Objectives of “Categorization” of Existing Substances (Cont’d) • First stages must be simple/pragmatic to address all substances, based on limited information for each • Simple tools • Subsequent stages must be discriminating to set true priorities for further work • Complex tools • Protective • Conservative choices in the absence of data • Challenge of the legislative construct • Relevance of persistence (P) or bioaccumulation (B) to human health ComET Peer Input meeting, Cincinnati, Nov. 8th/04

14. Products of “Categorization” under CEPA & Similar Programs (e.g., European Union) • Information gathering/global repositories for Existing Chemicals • More data/information on existing chemicals in the public domain • Development/refinement of predictive tools • Exposure (modelling) • Effect [(Quantitative) structure activity relationships (Q)SARs] • Predictive tools will help additionally focus testing and research ComET Peer Input meeting, Cincinnati, Nov. 8th/04

15. Process – Meeting the Mandate • Key: Development of robust proposals for review in public forum, including: • Public peer input on complex components • External peer review of various components by experts internationally • including those from stakeholder groups selected by independent party • Workshops of stakeholders to solicit input on specialized aspects • Interpreting use codes • Formal response to public comment ComET Peer Input meeting, Cincinnati, Nov. 8th/04

16. Process – Meeting the Mandate (Cont’d) • Interface internationally to access forward looking peer reviewed methodology addressing critical areas (in particular predictive tools) • Where industrial stakeholders could contribute most • Continuing updates to all stakeholders • industry, environmental groups, others • Communications pieces prepared & distributed as soon as various components conceptualized in period leading up to full proposals • http://www.hc-sc.gc.ca/exsd-dse ComET Peer Input meeting, Cincinnati, Nov. 8th/04

17. Efficiently Identifying Highest Priorities from a Human Health Perspective - Approach • Initial application of simple, discriminating tool on exposure to address all 23,000 substances to prioritize - “greatest potential for exposure” (GPE), “intermediate potential for exposure” (IPE) & “lowest potential for exposure” (LPE) • Draws on information submitted in compilation of the Domestic Substances List • Application of simple, discriminating tool to address hazard for all 23,000 substances • Draws on work completed internationally • Priority-based application of more complex tools to additionally refine list & order priorities • Exposure, dose-response • Priority setting takes into account where P or B has potential to meaningfully contribute to human exposure ComET Peer Input meeting, Cincinnati, Nov. 8th/04

18. PROPOSED FRAMEWORK FOR DSL CATEGORIZATION DOMESTIC SUBSTANCES LIST HEALTH CANADA ENVIRONMENT CANADA Substances that are Persistent and/or Bioaccumulative According to the Regulations Highest DSL Substances Identified as Hazardous to Human Health Substances that are Persistent and/or Bioaccumulative and Not “Inherently Toxic” to Non-human Organisms Substances that are Persistent and/or Bioaccumulative and “Inherently Toxic” to Non-human Organisms DSL Substances Ranked According to Potential For Exposure Lowest High Low EC Substances Identified for Screening Assessment Risk ranked list of Health Canada substances for screening ComET Peer Input meeting, Cincinnati, Nov. 8th/04

19. PROPOSED APPROACH FOR HEALTH-RELATED COMPONENTS OF DSL CATEGORIZATION DOMESTIC SUBSTANCES LIST Application of Simple Tools to Prioritize According to Potential for Exposure & Hazard for Entire DSL Health Priorities for Screening Assessment Prioritized on the Basis of Potential Risk to Human Health (Exposure & Toxicity) – ca. 1000 High GPE GPE DSL Substances Identified as Hazardous to Human Health Application of More Complex Tools to Refine Exposure Prioritization, Identify Hazardous Substances and Evaluate Exposure-Response IPE + IPE LPE LPE Low DSL Substances Ranked According to Potential For Exposure ComET Peer Input meeting, Cincinnati, Nov. 8th/04

20. DSL TOOLS - HEALTH • Exposure • SimET (Relative ranking of all DSL substances based on submitters (S),quantity (Q) and expert ranked use (ERU)) • ComET (Quantitative upper bound exposure estimate based upon use scenario, phys/chem properties & bioavailability) • Hazard [High (H) or Low (L)] • SimHaz (identification of high or low hazard compounds by various agencies based on weight of evidence) • ComHaz (Hierarchical approach for multiple endpoints & data sources [e.g., (Q)SAR] including weight of evidence) • Exposure-Response Tool • ERT (measures of exposure-response developed [where possible] on the basis of measured or predicted carcinogenic potency, reference values or effect levels) ComET Peer Input meeting, Cincinnati, Nov. 8th/04

21. Simple & Complex Exposure & Hazard Tools – What’s the Difference? • Complexity of the exposure tools relates simply to level of information • Simple exposure tool is based on limited information available for all substances • Complex exposure tool requires more information to be discriminating • Simple hazard tools bias to selection of data-rich compounds • i.e., all compounds are not treated the same way • Complex hazard tools address all compounds in the same manner, thereby identifying those which are priorities for both data generation and assessment ComET Peer Input meeting, Cincinnati, Nov. 8th/04

22. Quantity (Log) Number of Submitters Σ Use Code Indices 102 13227 8.4 S U Q ≥105 kg/yr 10% 10% 4.3 2 189 94.5 3 2 58.4 0 1 0 Σ Use Code Indices Initial GPE list of 849 substances IPE list of additional 1779 U Quantity Q Number of Submitters S Simple Exposure Tool (SimET):Relative Ranking for all DSL substances ComET Peer Input meeting, Cincinnati, Nov. 8th/04

23. Criteria for Greatest, Intermediate and Lowest Potential for Exposure (GPE, IPE & LPE) ComET Peer Input meeting, Cincinnati, Nov. 8th/04

24. Complex Exposure Tool (ComET) ComET Peer Input meeting, Cincinnati, Nov. 8th/04

25. Objectives of ComET – Existing Substances • Upper bound quantitative estimate of combined consumer & multimedia environmental exposure, taking into account accessible information on: • Use categories, sentinel product scenarios • Physical/chemical properties • Bioavailability • Emissions • Relevant to priority setting for both categorization and screening ComET Peer Input meeting, Cincinnati, Nov. 8th/04

26. Another Exposure Model – Why?????? • Need to develop a much larger number of exposure scenarios than currently exist • Need to integrate age specific exposure patterns particularly for products • Need to extend existing fugacity models to address media of human exposure • Provides the basis for additional refinement for higher level assessment by Health Canada and initiatives of other jurisdictions to systematically consider Existing Substances • Moving beyond the “data rich” focus of Existing Substances ComET Peer Input meeting, Cincinnati, Nov. 8th/04

27. SimHaz – the Simple Discriminating Hazard ToolWeight of Evidence for Specified Endpoints • High Hazard Lists • Cancer (IARC, EU, HC, US EPA etc.) • Genotoxicity (EU) • Developmental Toxicity (EU) • Reproductive Toxicity (EU) • Respiratory Sensitization (EU) • Low Hazard Lists • PMRA Pesticide Formulants 4A List • OECD Low Concern List • “Grandfathered” lists DON’T COUNT!! ComET Peer Input meeting, Cincinnati, Nov. 8th/04

28. ComHaz – Setting Aside Non Priorities • First stage: • Conservative hierarchical consideration of multiple health endpoints • Specific criteria for a range of endpoints selected on basis of potential public health impact and likelihood of available information • Conservative “first hit” for data (most recent considered initially) or QSAR for range of endpoints • Range of endpoints for genotoxicity • Low hazard compounds (e.g., those with potency less than criteria) set aside from further consideration • Focussing attention on higher priorities • Compounds not set aside go on to second stage of priority setting ComET Peer Input meeting, Cincinnati, Nov. 8th/04

29. ComHaz - Weight of Evidence to Define Priorities • Second stage: • Crude weight of evidence for data/(Q)SAR (latter restricted to cancer/genotoxicity) • Observation in numbers of species/sexes, route of administration • For genotoxicity, predictive strength of various assays (i.e., in vivo vs. in vitro) mutagenicity/clastogenicity assays > DNA damage > Indicator tests) • Consistency of repeated results • Robustness of (Q)SAR models ComET Peer Input meeting, Cincinnati, Nov. 8th/04

30. Applying the Tools - Health Priorities for Categorization – the “Maximal” List • Based on application of the “tools” to date, a maximum of 1904 substances (i.e., the draft “maximal” list) identified for further consideration in categorization for health • High (n=576), medium (n=989) and low likelihood (n=331) of remaining on list in 2006 • List released to focus the submission of solicited information on the identity, use and/or toxicity on any substance prioritized for further consideration • Reducing the list prior to 2006 • Focus on subset of high and the medium likelihood group where tools still being applied ComET Peer Input meeting, Cincinnati, Nov. 8th/04

31. How Will ComET contribute to refinement of the maximal list/risk ranking? Maximal List • For those in high likelihood and mid likelihood groups, could lead to compounds being set aside on the basis of exposure, alone Risk Ranking • Lower relative risk based on comparison with effect level or potency estimate leading to lower priority Remember: Priority setting is not risk assessment • but allows non priorities to be set aside, & • identifies priorities for further consideration ComET Peer Input meeting, Cincinnati, Nov. 8th/04

32. CEPA Existing Substances Program CATEGORIZATION of the Domestic Substances List (DSL) (First Phase) (n=23,000) Decisions of Other Jurisdictions Public Nominations STAGE 1 STAGE 2 Greatest Potential for Human Exposure Substances that are Persistent or Bioaccumulative “Inherently Toxic” to Humans “Inherently Toxic” to non-Human Organisms STAGE 3 SCREENING ASSESSMENT (Second Phase) No further action under this program Risk Management CEPA-Toxic IN-DEPTH ASSESSMENT - Priority Substances List (Third Phase) No further action under this program Risk Management CEPA-Toxic STAGE N-1 STAGE N ComET Peer Input meeting, Cincinnati, Nov. 8th/04

33. Screening Assessments for Health Priorities – Gaining Efficiencies in Assessment • Draws on work completed in other jurisdictions • Consideration of weight of evidence of hazard and “margins of exposure” which compare upper bounding estimates of exposure to lowest effect levels • High hazard, proposed “toxic” • Margin wide, “set aside” • Margin small, additional assessment • Decision making on the basis of adequacy of the margins, with clear delineation of confidence/uncertainties • draws on considerable collective experience within HC (simplified process) • Concise model, focussing on critical information ComET Peer Input meeting, Cincinnati, Nov. 8th/04

34. Framework for Screening – Health Priorities • Phase 1: Determination of Health-Related Priorities • Application of “tools” to identify health-priorities for screening assessment. • If substance is low health hazard/low exposure, not a health priority, no further work required (not 64c “CEPA-toxic”). • Phase 2: Issue Identification for Health-Related Priorities • For substances still prioritized once both simple and complex exposure and hazard tools applied, issue identification to highlight likely critical areas of focus based on input from relevant sources and parties • Phase 3: Screening Health Assessment • Screening health assessment of the nature of PFOS/PBDEs ComET Peer Input meeting, Cincinnati, Nov. 8th/04

35. History of Development of ComET • Work initiated in January/04 • First discussion on conceptual aspects between Lifeline and Health Canada – March/04 • Presentations to stakeholders – May/04 • CEPA Industry Coordinating Group, other industry groups and environmental interest groups • Engagement of Trent University – June/04 • Peer Input meeting – November/04 ComET Peer Input meeting, Cincinnati, Nov. 8th/04

36. Objectives of this Peer Input Meeting on ComET • Increased understanding of how the “tool” will contribute not only to the CEPA program but for other Governments/industry • Solicit input/information/comment on the architecture/data to populate for decision making on the program • Encourage collaboration to avoid duplication and maximize use of resources to contribute to development of increasingly more refined models • more scenarios • increased complexity ComET Peer Input meeting, Cincinnati, Nov. 8th/04

37. Keep in Mind • Development of this “tool” (ComET) is a work in progress • Default values provided principally as examples, for illustration, currently • Not encompassing at this stage • Continuing suggestions are welcome, but this is NOT peer review • Deadline will determine form of peer review pre 2006 • It is the “tool” (ComET) which is the focus of this meeting, not the substances • Substances for illustrative purposes, only • “Tool” currently a spreadsheet but form will change ComET Peer Input meeting, Cincinnati, Nov. 8th/04

38. More Information? • Health Canada Existing Substances Division Website – http://www.hc-sc.gc.ca/exsd-dse • Health Canada Existing Substances Mailing List – http://www.hc-sc.gc.ca/hecs-sesc/exsd/listserv.htm • CEPA Registry – (http://www.ec.ca/CEPARegistry) ComET Peer Input meeting, Cincinnati, Nov. 8th/04