Exposure-based Prioritization – Health Canada Experience under the Canadian Environmental Protection Act

1. Exposure-based Prioritization – Health Canada Experience under the Canadian Environmental Protection Act Christine Norman Healthy Environments and Consumer Safety Branch, Health Canada

2. Introduction • Context and Legislative framework • Categorization of the Domestic Substances List (DSL) • exposure tools used • Chemicals Management Plan • Priority –setting • Lessons learned from high priorities (‘Challenge’) • Use of exposure-based prioritization within a sector – petroleum case study. • Remaining Priorities • Scope of remaining priorities • Towards a priority-setting framework • Potential role of exposure triggers in screening assessments • Collaboration Opportunities – tool development and data generation

3. Context and Legislative Framework • Domestic Substances List (DSL) - list of substances that are/were “in commerce” in Canada (1984-1986) – “existing substances” • Canadian Environmental Protection Act (CEPA) 1999 required Ministers of Environment and Health to categorize the 23,000 substances on the DSL according to specific criteria to identify substances that • May present, to individuals in Canada, the greatest potential for exposure;or • Are persistent (P) orbioaccumulative (B), in accordance with the regulations, and inherently toxic to humans or to non-human organisms, as determined by laboratory or other studies • Categorization represented a priority setting exercise that involved the systematic identification of substances that should be subject to screening assessments and management controls if applicable • Technical components of the methodology was subject to peer input and peer review • Consultation was done with stakeholders and the public

4. Categorization of the DSL • Simple tools were applied for both exposure and hazard to focus on highest priorities (SimET and SimHaz) • SimET: a relative ranking of all substances based on 3 lines of evidence: • Quantity in commerce • Number of submitters, and • Sum of expert ranked use codes • Based on initial compilation data for the DSL (1984 to 1986) - only data available for ALL substances on the DSL • Resulted in substances being grouped as • greatest potential for exposure (GPE), • intermediate potential for exposure (IPE) or, • lowest potential for exposure (LPE)

5. Categorization Criteria • The criteria for categorization for each of these lines of evidence were chosen as: • quantity of use (Q) ≥1 000 000 kg/year (2413 substances); • Because we summed the top end of the reported ranges, this actually accounts for all substances that were definitely used at >100 000 kg/year, which is consistent with multiple international HPV programs • the top 10% of the rank order of the number of submitters (S) (≥4 submitters) (2665 substances); • and the top 10% of the rank order of indices of use (U) (score ≥414.1) (2226 substances). • The chosen criteria for number of submitters and use are arbitrary, but consistent with that adopted for quantity of use (i.e., prioritizes approximately the top 10% in each category) • Substances would be considered as priorities for further consideration only if they met the criterion for each of the three lines of evidence.

6. The Categorization Process 23,000 substances on the Domestic Substances List (DSL) Greatest Potential for Human Exposure Substances that are Persistent or Bioaccumulative Inherently Toxic to Humans Inherently Toxic to non-Human Organisms Screening Assessment Risk management No further action under this program Addition to Priority Substances List (PSL) Page 6

7. Canada’s Chemicals Management Plan • The Chemicals Management Plan (CMP) is the Government of Canada’s response to the Strategic Approach to International Chemicals Management (SAICM). It is designed to meet the 2020 goals set by the World Summit on Sustainable Development for sound management of chemicals. • The Chemicals Management Plan provides a framework for assessment and management of approx. 4,300 substances identified through categorization. • The CMP integrates federal programs into a single strategy to ensure that chemicals are managed appropriately in order to prevent harm to Canadians and their environment. Page 7

8. 2007-2012: • Challenge to industry • Petroleum sector • Controls ~500 high priorities • Support through: • Research, monitoring, surveillance • Inventory update • International collaboration 4,300 Priorities from Categorization 2007 Rapid screening ~3000 med priorities ~750 low priorities Complete by 2020 From 23,000 to 4,300 Substances Page 8

9. High Priority Substances • High priorities for action included substances (~500): • That met each of the ecological categorization criteria (persistence (P), bioaccumulation (B) and inherent toxicity to aquatic organisms (iT) ; and • That met the criteria for greatest or intermediate potential for exposure (GPE or IPE) and were identified as posing a high hazard to human health (i.e., classified by another agency on the basis of carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity as identified by the Simple Hazard Tool) • Within the Chemicals Management Plan, the top priorities (identified through categorization) are addressed through 3 components: • Significant New Activity (SNAcs) for substances believed to not be in commerce (~150 PBiT SNAcs) • Challenge Programfor substances believed to be in commerce (~ 200substances) • Petroleum Sector Stream – a focused sectoral approach (~160 Substances)

10. STREAM 2: Industry restricted petroleum substances (16 substances) STREAM 3: Fuels (11 substances) STREAM 4: Petroleum substances in consumer products (65 substances) Petroleum – Exposure-based Prioritization Approximately 160 substances Not part of petroleum sector Manufactured or imported by the petroleum sector? no yes no leaving facility? yes Industrial use only (e.g. feedstocks, fuel) Final products used by the public or by other sectors STREAM 1: Site restricted petroleum substances (69 substances)

11. Low Priority Substances • A number of PiTeco or BiTeco substances (1066) identified through categorization have a low potential for risk due to low reported volumes during compilation of the DSL • Ecological rapid screening approaches were employed for risk assessment using a worst-case scenario model to confirm the likelihood that a substance may not cause ecological harm • Draft results for the ecological assessment were released for public comment on June 23, 2007 • 1066 substances were subject to this approach • 754 substances were found to be “not harmful” to the environment according the definition in CEPA 1999 • The government proposes to include the substances in the future inventory update to validate assumptions, conduct monitoring where appropriate and revisit some of the substances as part of assessments of “families of chemicals” at a later date • 312 substances require further assessment and were re-prioritized into the group of medium priority substances

12. Exposure Prioritization and Assessment Tools - Lessons learned to date • Limitations to conducting a priority-setting exercise based on dated inventory data (1984-1986). • Approx. 45% of substances in Challenge Batches 1-6 were not in commerce based on surveys for 2006 calendar year. • Indirect exposures (i.e., environmental media) do not typically drive assessment outcomes (though indoor air is a source of potential exposure). • Lack of approaches to model far-field exposure to inorganics • Direct exposures (i.e., consumer products) more typically key driver in assessment outcome. However, mandatory information-gathering tools inadequate to collect necessary inputs to inform exposure assessment. • Near-field - public comments on assessments criticized ‘worst case’ nature of these exposure characterizations. • Exposure to substances that are present only as a residual/by-product often drive assessment outcomes (e.g., residual monomers). • Substance-by-substance approach inefficient for both risk assessment and risk management activities

13. Medium Priorities - Scope

14. Medium Priorities – Data Availability Looked at the data available in several databases (Toxline, HSDB, HPD, ATSDR, etc.) to get an indication of general toxicity and exposure data availability in the open literature.

15. Proposed Priority Setting Framework • Other Feeder Mechanisms • Industry information • Other jurisdiction decision • International assessment or data collection • Public nominations • New Substance notifications • Emerging science/monitoring DSL Categorization • Setting Priorities • Considerations for assigning higher priority • Potential for human exposure to vulnerable populations • Potential for direct exposure through presence in consumer products • Precursors and analogues of CEPA Toxic substances or PB substances • High volume (HPV), inherently toxic substances • Considerations for assigning lower priority • Low volume, «not in commerce» • Reduced concern, post-categorization changes in decisions • Finding Efficiencies • Grouping based on chemical properties, use, mode of action or other considerations • Sectoral priorities and approaches • Thematic or Place Based Groupings (eg: water, waste…) • Aligning/collaboration with international/national programs Data Gap Filling, Research and Monitoring* Inventory Update *with the option to move forward in the absence of new information Sectoral Clusters for RA/RM Rapid screening approaches Individual substance assessments SNAc’s Chemical groups assessments

16. Potential Role of Exposure Triggers in Screening Assessments Substance Identity Check s. 71 Reported Activity > 100 kg (in commerce) No Yes Quantity in commerce >1000 kg (possible exposure through env. media) No Yes Direct exposure sources in Canada? Screening Assessment No No High Hazard Flag? Not 64(c) Yes Yes Regulatory Decision to be made (e.g., SNAc) Screening Assessment

17. Tool Development - Complex Exposure Tool (ComET) • Quantitative plausible maximum age-specific estimates of environmental and consumer exposure based upon use scenario [sentinel product and emissions], physical/chemical properties and bioavailability • ComET is composed of two components – Near-field and Far-field • Was not applied during categorization, but will be considered to characterize exposures in screening assessments

18. Complex Exposure Tool (ComET)(Cont’d) • Near-field Exposure - Developed by Health Canada and The LifeLine Group • Purpose is to provide quantitative estimates of exposure from direct use of products, using maximum concentrations identified for a substances for a particular use. • Concept of sentinel product • Work planned with LifeLine to expand near- field exposure applications of the ConsExpo tool for Canada • Far-field Model – Developed by J. Arnot, D. Mackay, E. Webster, Canadian Environmental Modelling Centre (CEMC) at Trent University • The Health Canada Farfield (HCF) Exposure Model is a tool designed on steady-state level III fugacity model which brings together information on chemical partitioning, degradation, environmental fate and transport, and food web bioaccumulation for assessing human age class specific exposures from chemicals released to the environment • Undergone publication peer-review and schedulled for publication • Exploring development of potential approaches for inorganic substances.

19. Assessment Strategies and Data Generation at Health Canada Assessment Strategies • Grouping substances (e.g. colourants, flame retardants) • Aggregate /cumulative approaches for certain classes Data generation (for priority-setting and assessment purposes) • Canadian Health Measures Survey • Indoor air surveys • Biomonitoring • Indoor Air – building materials • Dermal absorption - in vitro methodology development; defaults in absence of data.

20. Collaboration Opportunities • Priority-setting and assessment tool development • Development of common exposure triggers • Methodology for the characterization of exposure to substances in consumer products • Joint priority-setting/scheduling of priorities in order to share information and assessment workload. • Assessment strategies for groups • Data generation

21. Collaboration Opportunities