March, 2009 An Overview of the Chemicals Management Plan

Page 2 Overview Context: Results of DSL Categorization –What is DSL Categorization –Consistent way to identify priorities –Plan to address “categorized substances” Chemicals Management Plan –Key objectives –The Challenge –Timelines –Progress to date Additional Features of the CMP

What is Categorization? Mandated under CEPA 1999 (Section 73) –Ministers were required to categorize the 23,000 substances on the DSL by September 14, 2006 –Categorization is a prioritization process that involves the systematic identification of substances on the DSL that should be subject to a screening assessment (Section 74, CEPA 1999) Identify substances based on available information, that: –May present, to individuals in Canada, the greatest potential for exposure; or –Are persistent (P) or bioaccumulative (B), in accordance with the Persistence and Bioaccumulation Regulations, and inherently toxic to humans or to non-human organisms, as determined by lab or other studies – Page 3

Completion of Categorization is an opportunity Government of Canada scientists, in cooperation with industry and health and environmental groups, completed the categorization process by the Sept 14, 2006 deadline Until now, Canada has not had a consistent information base on which the thousands of existing substances potentially in commercial use could be compared and prioritized Since 1994, Canada has assessed and managed the risks to environment and human health from new substances being imported into or manufactured in Canada Internationally, new initiatives such as REACH and ongoing programs focused on High Production Volume Programs (e.g. OECD, US) provided Canada with an opportunity to identify its own path forward Page 4

Page 5 Categorization of Existing Substances 4,300 substance on Canada’s DSL have been identified as requiring further work/action –4000 met the categorization criteria –300 warrant further attention from a human health perspective Considerations for the first round of priority setting and upcoming actions: –The degree of hazard/risk –Commercial activity in Canada –Existing/ongoing risk assessment and risk management activities –Opportunities to engage internationally and “share the work” for a global issue

Page 6 From 23,000 to 4300 Substances 4300 Priorities from Categorization 2600 Med Priorities 500 High Priorities 1200 Low Priorities

Page 7 The Chemicals Management Plan (CMP) – a new era in chemicals management in Canada An important part of the CMP is the assessment and management, by 2020, of the risks associated with 4300 legacy substances identified through categorization. The Chemicals Management Plan aims to bring all existing federal programs together into a single strategy to ensure that chemicals are managed appropriately to prevent harm to Canadians and their environment. It is science-based and specifically designed to protect human health and the environment through four major areas of action: –Increasing industry stewardship role in actively managing the risks posed by the chemicals they produce and use; –Taking action on chemical substances of high concern; –Taking action with specific industry sectors; and –Investing in research, monitoring and surveillance;

Page 8 Key Objectives of Canada’s Chemicals Management Plan (CMP) Significantly strengthen the existing substances regime: Categorization established a new information baseline that sets clear priorities for action that are science based Integrate government activities: The Chemicals Management Plan will strengthen CEPA’s coordination with other federal statutes, including: Hazardous Products Act, Food & Drugs Act, and Pest Control Products Act Establish government accountability: The Plan draws on: –Enhanced monitoring and surveillance activities to identify priorities and measure effectiveness of regulatory actions –Increased research activities to ensure that action is informed by best available science –Enhanced risk communications to Canadians –Public web portal to ensure consistent access to information –A cyclical update of the Domestic Substances List that will require industry to report on use and volume of substances on the Canadian market Strengthen industry’s role by proactively identifying and safely managing risks associated with chemicals they produce and use

Page 9 Chemicals Management Plan: CEPA Program Elements Stakeholder feedback during design indicated a clear preference for a phased approach driven by priorities The initial focus of the Chemicals Management Plan is addressed through (high priorities): –Challenge Initiative for high concern substances in commerce –Significant new activity controls (SNAcs) for high concern substances no longer in commerce –Petroleum sector as a priority with unique risk assessment and management circumstances –Prohibitions on a set of substances and creation of the virtual elimination list to demonstrate commitment and action by government –Rapid screening of lower risk chemical substances for market certainty –Foundational work (international engagement, research and science, monitoring, inventory update) to inform and set priorities for next phase of priority substances

Page 10 What is the Challenge? A Notice was published in the Canada Gazette, Part I December 2006 outlining the Government of Canada’s intended action for the Challenge It is a plan for the assessment and management of substances believed to be in-commerce and identified as high priorities for action as a result of Categorization This includes substances: –That met each of the ecological categorization criteria (persistence (P), bioaccumulation (B) and inherent toxicity to aquatic organisms (iT), and believed to be in commerce in Canada and/or; –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 (evidence of carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity) –This was complemented with industry survey data to indicate that these substances were still in commerce today

Page 11 The Challenge: The Top 200 Priorities for Action The Government of Canada is using existing legal tools and the regulatory process to challenge industry to provide new information The federal government is publishing, in 12 batches of substances every three months (started in February 2007), profiles of chemical substances and complementary mandatory surveys. All challenge substances will be released within 3 years. Manufacturers, importers and users must submit the specific information outlined in the survey by the specified deadline (four month timeframe to respond). Relevant parties will be challenged to submit the specific information detailed in the challenge questionnaire, and comments on substance profiles, within 6 months. Government scientists will then have a maximum of 6 months to publish a screening level risk assessment. The absence of information will not preclude the government from taking action that safeguards human heaIth and the environment

Page 12 Timelines for the Challenge Release of substance profile, mandatory survey, questionnaire 4 Months Option 1: No New Data 90 Days Draft Screening Assessment Released (77(1)) and Risk Management Scope Documents 60 Days 6 Months Public comment period Option 2: New Data Received 6 Months Review Data Draft Screening Assessment Released (77(1)) and Risk Management Scope Documents 6 Months Ministers Final Screening Assessment Released (77(6)) 60 Days Public comment period Ministers Final Screening Assessment Released (77(6)) 2 Months Potential for extension for mandatory component Call for Information

Page 13 The Challenge: progress to date Milestones Batch # 12 + BPA Launch of batch: Substance profile of technical data; 4-6 month call for information (s.71 Notice, voluntary questionnaire) √√√√√√√ √ Not yet initiated Close of call for information & compilation of data √√√√√ √ Not yet initiated Publication of Draft Screening Assessment Reports (SAR) and risk management scopes for a 60-day public comment period √√√ (4 of 19 proposed toxic) √ (3 of 18 proposed toxic) Not yet initiated Publication of Final SAR and proposed risk management approach (60-day public comment period for risk management approach) √ (9 of 15 toxic) √ (9 of 17 toxic) Not yet initiated

Page 14 Risk Assessment and Management Process for Existing Substances EC HC Draft Environmental Assessment s.64 (a) & (b) Proposed conclusion “Toxic or non-toxic” s.77(1) Maximum 18 months Maximum 24 months AssessmentManagement Self-imposed Timelines for Challenge Draft Human Health Assessment s.64 (c) Ministers Final conclusion “Toxic or non-toxic” s.77(6) Proposed Order “Addition to List of Toxic Substances” (Schedule 1 of CEPA) s.77(9) & 90(1) Final Order “Addition to List of Toxic Substances” (Schedule 1 of CEPA) s.77(9) & 90(1) Proposed RM Instrument s. 91(1) Final RM Instrument s. 91(1) 60-day public comment period Public consultation on proposed conclusion Ministerial decision-making Governor-in-council decision-making Ministerial or Governor-in-council decision-making

Page 15 Additional Features of the CMP Research –Generation and dissemination of science-based information to fill information gaps in support of risk assessment and risk management Monitoring and Surveillance –Increased emphasis on monitoring effectiveness of management tools, as well as identifying emerging issues and trends Outreach and Stakeholder Engagement –CMP Stakeholder Advisory Council; Challenge Advisory Panel International –Explore opportunities for advancing domestic priorities through international programmes (e.g., HPV, REACH) –Regulatory Cooperation (US, EU, Australia) Exchange of information and knowledge Coordination of risk assessment and risk management

Page 16 Contact Information Chemical Substances Website: Hotline and mailbox for the Challenge Program DSL Surveys Coordinator Existing Substances Program Gatineau, QC K1A 0H3 telephone: / ; fax: / ; or –All calls and data submissions, including written comments, should be directed to this contact point –.