Categorization and Screening of the Domestic Substances List Path forward towards ecological prioritization of substances for assessment Existing Substances Branch Environment Canada

The results (April 2005) Quantity reported in 1986 (# on HC Maximal list) Preliminary Ecological Categorization Decisions 0 to >1T1T to >1000T >=1000TUnknown quantity Total Meets Categorization criteria 188 (20)319 (40)100 (32)20 (2) 627 (94) high confidence(blue)(yellow)(purple)(orange) Meets Categorization criteria 507 (12)768 (23)178 (39)48 (2) 1501 (76) medium confidence(blue)(yellow)(purple)(orange) Meets Categorization criteria 495 (0)690 (7)104 (25)21 (1) 1310 (33) low confidence(blue)(yellow)(purple)(orange) Uncertain312 (8)354 (42)390 (288)4 (0) 1060 (338) and data poor(green) (purple)(orange) Under review810 (0)1604 (115)295 (116)47 (2) 2756 (233) for PBiT(green) P and/or B, not iT3,658 (442) 3658 (442) to non-human organisms(white) Not P and Not B8,290 (416) 8290 (416) (red) Low Concern3,236 (146) 3236 (146) (red) Total Substances 22,438 (1778)

Timelines / Next Steps DateMilestone July 28, 2005Multi-stakeholder meeting on prioritization. July, 2005Updated Categorization CD. Preliminary categorization decisions for all but the uncertain substances. Aug/ Sept, 2005Discussion paper on prioritization (post September 2006) September, 2005Deadline for submitting experimental data to support the categorization of discrete organic and inorganic substances. October, 2005Updated Categorization CD. Decisions on uncertain substances & changes based on industry submissions. December, 2005Deadline for submitting experimental data to support the categorization of polymers, organometallics, and UVCBs. January, 2006Updated Categorization CD. Changes based on industry submissions. April, 2006Final draft Categorization CD. July, 2006Final Categorization CD. September, 2006Statutory deadline for publishing the results of the Categorization of the DSL.

Deadlines for Data Submission  September 2005: Discrete organics & inorganics  December 2005: Other substances  If data cannot be submitted by these dates, extensions may be requested.  Requests must include a plan outlining the work being undertaken, status, next steps, and timelines.  Requests must be submitted well in advance of these deadlines, and will be available for public review (Categorization CD).  Data received after the deadline may not be processed in time for the September, 2006 deadline.

Categorization Results to Date  Of the 19,700 (of 22,400) substances for which we have preliminary categorization decisions, there is evidence that 3400 meet ecological categorization criteria 100 PBiT with data of high certainty 200 PBiT with data of low certainty 400 High volume PiT or BiT 1000 Medium Volume PiT or BiT with data of high or medium certainty 700 Medium Volume PiT or BiT with data of low certainty 1200 Low Volume PiT or BiT (<1000kg)  A further 1000 substances are Uncertain because they have no data

Some Of These Substances Are Already Being Addressed  For many of these substances actions have already been taken, or will be taken under CEPA  Many others are already undergoing testing in HPV Programs  Some of the substances meeting ecological categorization criteria also meet health categorization criteria, though the overlap is not high

Characteristics Context # on April 2005 CD [category] # HPV program (US/OECD /ICCA) # HC Maximal list CEPA (PSL, Schedule 1, PFA survey) Pilot Project (other SA) P (air) B iTGlobal Issues: POPS Stockholm, UNECE 21 [0] 8341 (+ 10 ) P (other) B iTRegional Issues: Great Lakes, SMOC 295 [57] High Volume {Uncertain, data poor, model difficult} Data Collection is ongoing: US HPV and OECD/ICCA 382 [351] {390} [11] <130* (Organics) 129 {288} Medium Volume High & medium confidence Priority setting with Stakeholders 1087 [301] <133* (Organics) Low VolumeLow Priority or Set aside1190 [126] <28* (Organics) Uncertain, data poor, {Low confidence medium volume} Reverse Onus International collaboration to fill data gaps 666 [171] {690} [159] x Health Canada priorities Maximal list1892 * Preliminary numbers; X means not available Ongoing Actions and Linkages

Setting The Context For Communicating Categorization Results  There is much interest in understanding what will happen after categorization is complete as it is clear that the results of categorization will require a long term response from government, industry and public interest groups  Communicating the results of categorization will be facilitated if these results are set in the context of next steps  Assessment is not the only next step for many substances  Therefore, a mechanism must be developed to group substances according to the anticipated actions by government, industry and stakeholders in 2006

What Are The Possible Next Steps After Categorization?  In the next 20 years Canada and other jurisdictions will continue to work towards understanding substances in commerce Some substances can proceed immediately to risk assessment Other substances require additional data generation to reduce uncertainty in their categorization decision New research needs to be conducted particularly in the area of environmental monitoring, and model development Meanwhile, the government needs to continue working with other jurisdictions. Results of the US & OECD HPV programs and the EU REACH program need to be taken into consideration Industry needs to be responsible and accept the “onus” placed on them to understand the impact of substances that they produce or market

Path Forward - Implementation of ecological prioritization framework  June 1: EC/HC/ICG/CEN meeting where prioritization framework concept was introduced.  July 28: stakeholder subgroup meeting to identify mutually acceptable considerations for prioritization  Summer 2005: discussion paper outlining overall objectives for prioritization of categorized substances.  Define how to use the sorting tools in the next steps Severity scale (mechanical process) Certainty scale (mechanical process) Information from categorization Information from new substances requirements  We commit to maintain the open, transparent and consultative process we have used for categorization

The Framework For Action On Substances Meeting Categorization Criteria Priority to Fill Data Gaps  Higher severity/ lower certainty  Fill information gap through science and monitoring  Actively engage international players (influence)  Challenge voluntary industry RM action, or data generation Priority for Assessment  High certainty & severity  Higher volume and or hazard  Precautionary RM action where needed Monitor Progress  Lower severity & certainty  Support voluntary industry activity to fill data gaps  Passively align with existing international data gathering or assessment activities (communicate)  Implement international feeder by monitoring RA/RM activities in other countries  Implement provisions to put onus on industry (S. 70 feeder) Low Priority for Action  Lower severity / higher certainty  Lower volume  Low priority for assessment  Generic exposure tools to set aside  Communicate low expectation for immediate action  Monitor 6 feeders

Path Forward for: Substances identified as P and B (n=314)  P and B substances are the ecological highest priority for assessment to determine if these substances pose an ecological risk  For substances that are P, exposure can not easily be reduced by discontinuing production Problems caused by persistent chemicals are, therefore, long-lasting  Persistent substances that are bioaccumulative concentrate up to several orders of magnitude. They can reach concentrations where adverse effects occur even at low levels of exposure in the environment  Many P and B substances have low confidence categorization decisions so priority after 2006 is to improve the quality of the data upon which decision is made  Group substances based on chemical categories of P&Bs.

Trial Binning of 1660 Organic Substances “Categorized In” Based on Hazard Priority for assessment 117 CAS#s (98 PBiTs) Low priority for action 117 CAS#s Priority to fill data gaps 550 CAS#s (218 PBiTs) Monitor progress 876 CAS#s

Path Forward for Purple: High volume, > 1000 tonnes (n=382)  Determine which substances have already been addressed domestically, such as PSL, schedule 1 (done)  Determine substance status in international high volume programs (done)  Those substances with SIDS datasets generated internationally can proceed to screening assessments  Verify whether the timelines for generating the SIDS data in international HPV programs are compatible with our domestic scheduling (to be done as part of phase 2 of priority setting) Issue 1: Canada is an 80% import market. As such not many substances are originating in the country. Existing substances risk are a developed world problem. Issue 2: Categorization has confirmed the global lack of data on chemicals, Issue 3: the lack of significant progress on important international initiatives that hold promise is cause for concern Issue 4: We are currently at least 10 years ahead of REACH

Path Forward for Yellows: Categorized in with medium & high confidence (n= 1087)  Distributed among 4 quadrants  Medium confidence = priority for data- gap filling  High confidence = higher priorities for assessment/ further actions  Rounds 1&2 = some yellows, or as part of category approach  Round 3 = larger number of yellows, or as part of category approach

Path Forward for Yellows: Categorized in but low confidence (n= 690)  Weight of evidence points in the direction that the substance meets the categorization criteria  Simplified s.71 survey to find out which ones are not in commerce (based on new survey format)  For those in commerce, voluntary challenge to industry to fill data gap or to accept the “onus” of risk managing  For those not in commerce, consider the use of SNAc’s to ensure data gaps are filled before the substance is re-introduced on the market (trigger of 1 tonne for example?)  These substances will likely be initially lower priorities for screening assessments unless data is received  P and B substances of medium volume are not included in this approach

Path Forward for Blues: Low volume, < 1 tonne (n=1190)  Select some priorities for screening assessment based on P and/or iT. (Cherry picking)  Some of these substances could be included in a category approach (determined during phase 2) based on priorities of other related substances For example, a group assessment of nitro musks would include low volume nitro musks These substances would not be driving assessment priorities  For substances not selected as priorities and that do not fall in a category, use a generic exposure tool such as ChemSim for a tier 1 screening assessment or to justify very low priority for assessment (set aside)  Provide industry with section 70 guidance on what types or future sources of exposure to notify  Persistent and bioaccumulative substances are not included in this approach

Generic Exposure Scenarios  Generic exposure scenarios would be used to refine binning of substances.  Combination of scenarios could be used to support the setting aside of substances that are low priority for further action. Generic exposure scenario in ChemSim could be compared to acute toxicity data used for categorization.

Mechanical Priority Setting Activities Before 2006 Will Be Augmented  The mechanical sorting will be refined using planning tools Assessment and management activities in other countries International HPV programs Category approaches Ongoing research and monitoring activities Potential use of Significant New Activities Provisions Results from section 71 surveys Use of section 70

After 2006 Additional Priority Setting Will Need to Occur  Post categorization, work can begin on setting priorities for assessment within smaller groups of substances  A priority setting and scheduling process needs To be done in conjunction with Health Canada Set priorities periodically (as opposed to ongoing) Be able to accommodate emerging priorities that are identified through mechanisms other than categorization (ie emerging science, new substances) Be cognisant of ongoing initiatives and work in other jurisdictions Scaled to the resources of government, industry and other stakeholders Be transparent and have appropriate engagement

1.Categorizatio n 2.New Substances Notification 3.Industry Information 4.International Assessment and Data Collection 5.Emerging Science 6.Public Nominations 7.Provincial or International Decisions 7 Feeders S. 74 Categorized “in” S. 68 Not Categorized “in” but further work Includes uncertain S. 68 or S. 77 Other substances identified for further review eg.: Organotins, BFR’s, PFOS, PFCA, PCN, CP’s, organoperoxy, organosilicon Could overlap with categorization Prioritization I (Multi-stakeholder) Priority for Assessment High certainty & severity Higher volume and/or hazard Precautionary RM action where needed Actively Fill Data Gaps Higher severity/lower certainty Fill information gap through science and monitoring Actively engage international players (influence) Challenge voluntary industry RM action, or data generation Passively Align with Other Programs Lower severity & certainty Support voluntary industry activity to fill data gaps Passively align with existing international data gathering or assessment activities (communicate) Implement international feeder by monitoring RA/RM activities in other countries Low Priority for Action Lower severity/higher certainty Lower volume Low priority for assessment Generic exposure tools to set aside Communicate low expectation for immediate action S. 71 Surveys Complete HPV Assessments in other jurisdictions NSN information database Set government research agenda Communicate data gaps and actively engage other jurisdictions Challenge industry S. 71 data generation Develop tools/methods (OECD) SNAC’s HPV Reverse onus on industry Industry research programs REACH implementation EPA prioritization discussions NSN new data Research programs S. 70 NSN trigger and information requirement REACH exemptions S. 71 other Gazette Notices to definitely set aside Use 6 feeders to re- assess 7 Feeder Contribution to Next Steps Report on results of assessment Report on active data gap filling Report on results of passive alignment Report on new information from 7 feeders Prioritization II (Multi-stakeholder) Prioritization III (Multi-stakeholder) Identification of Substances Contributing to identification of all hazardous substances Prioritization Outcome PBiT PiT & BiT Includes low confidence Development of mutually acceptable (Multi-stakeholder) set of considerations for setting priorities 2005