Sound Management of Chemicals (SMOC) March 4 th – 7 th, 2008 Tucson, Arizona Update on Canada’s Domestic Chemicals Management Plan

Objective/Purpose Provide an update of the Chemicals Management Plan (CMP) including: –Review of policy context, key policy objectives, program design –Key initiatives from the past year (SNAC, Rapid Screening and Challenge) –Medium Priority Substances –Enhanced Monitoring, Surveillance and research –Activities under the Pest Control Products Act –Activities under the Food and Drugs Act –International Regulatory Cooperation Page 2

Policy Context Canada’s Chemicals Management Plan describes the Government’s overall approach to assess and manage the risks associated with 4300 legacy substances identified through categorization by 2020 –These 4300 substances were prioritized into high (500), medium (2600) and low concern substances (1200) –Implementation of the different initiatives under the CMP are well underway The Government is using this information to: –Inform completion of obligatory risk assessments –Launch new programs under the Chemicals Management Plan (e.g. Challenge) –Transform how it protects Canadians and their environment from risks associated with chemicals The Canadian approach is generating a high level of interest among Canadian stakeholders and internationally Page 3

Key Policy Objectives Set clear priorities for assessing and managing chemical substances used in Canada Integrate chemical management activities with all relevant federal legislation Enhance health monitoring and surveillance of chemical substances of concerns in the environment Inform Canadians about the potential risks of chemical substances Provide an updated inventory of chemical substances used in Canada Strengthen industry’s stewardship role in proactively managing risks associated with chemicals they produce and use Cooperate with international programs related to chemicals management Page 4

The CMP continuum: The key to an efficient science-based regulatory regime for chemicals Support for Research: The Government will enhance regulatory science by leading research and partnering with external research bodies to inform risk assessments and regulatory interventions –Thus ensuring that action on the part of governments, Canadians, and industry are informed by the best available science Integrated Monitoring: The Government will build on the new baseline of information from categorization by implementing a national health and environment monitoring and surveillance program that: –Identifies emerging priorities and tracks Canadians’ exposure to toxic substances; and, –Measures the effectiveness of our regulatory actions so that we know what works best Inventory Update: The Government will develop and implement a cyclical inventory update provision for CEPA’s Domestic Substances List This will require industry to report on the substances they use, and the volume of these substances on the Canadian market Page 5

The initial focus of the Chemicals Management Plan is addressed through: Challenge Initiative for about 200 high concern substances in commerce – more information follows Issuing Significant new activity controls (SNAcs) notices for high concern substances no longer in commerce. Notices have been proposed for approximately 150 high-hazard (PBiT) chemical substances. This means industry must provide data (under the New Substances Program) to be reviewed by the Government before any of the chemical substances on the list can be re-introduced into Canada Rapid screening of lower risk chemical substances using a worst-case scenario model to confirm the likelihood that a substance may not cause ecological harm. Out of the 1066 substances subject to this approach, 754 were proposed “not toxic” in June 2007 The remaining medium priority substances are expected to be addressed in total by Page 6

Challenge to Stakeholders The Government is placing the onus on stakeholders to provide information that improves, where possible, knowledge for risk assessment and identification of industrial best practices to set benchmarks for risk management and product stewardship The government is predisposed to conclude “toxic” should no new information come forward, and institute control measures that safeguard human health and the environment The Government is releasing 12 batches of substances that include substance profiles, mandatory surveys and voluntary questionnaires. To date, 5 batches have been released (see Annex) Status of Batch 1: Draft screening assessment reports (SARs) and risk management scope documents were published on Jan. 19, 2008 for public comment. Comment period ends on March 19, 2008 Final SARs and proposed risk management approaches anticipated to be published in July 2008 Reactions to date: High interest in the Challenge from Canadian stakeholders and interest has also been expressed from other governments Over 3350 inquiries (via and phone) have been received Via their Canadian operations, many international chemical firms are providing information through the mandatory surveys Page 7

Batch 1 Outcomes for draft SARs 12 substances are proposed toxic and 3 are proposed not toxic under CEPA For those proposed toxic: Recommendation is to add to Schedule 1 of CEPA of these substances are a concern to human health –3 Toluene diisocyanates (TDIs), Naphthalene, 1,2-Benzenediol, 1,4-Benzenediol, Methyloxirane, Ethyloxirane 4 of these substances are a concern to the environment –For those proposed toxic to the environment, due to their inherent properties, they will also be recommended for Virtual Elimination (VE) –1 Propanedinitrile (yellow dye), 3 organo-peroxides For those substances that are proposed not toxic: Recommendation is no further action –Pigment Red 187, Pigment Orange 38, Pigment red 247:1 Page 8

Enhanced monitoring, surveillance, and research Objectives: Identification of emerging chemical risks and tracking trends for known priority chemicals Development of an exposure baseline (human and ecological) against which the effectiveness of control actions can be measured. Health Biomonitoring Tools: Canadian Health Measures Survey (CHMS) –measures of chemical exposures in Canadians aged 6-79 Maternal Infant Research on Environmental Chemicals (MIREC) –Research study on health risks from exposure to metals during pregnancy; data on exposure to a range of environmental chemicals Ecological Monitoring and Surveillance Tools: Ambient Environmental Monitoring and Surveillance: –Water quality monitoring (chemical, biological) –Air quality monitoring (transport, transformation and deposition of contaminants) –Wildlife exposure and surveillance Page 9

Activities under the Pest Control Products Act The Government has initiated the re-evaluation of a number of older pesticides registered before 1995, to determine whether or not they meet today’s health and environmental standards. Canada has addressed 241 of the 401 active ingredients to be re-evaluated by New product registrations: Registered 11 new pesticide active ingredients, including 7 reduced-risk actives. Registered 382 new minor crop uses, which is defined as the addition of a new crop or site to the use pattern of an active ingredient. Incident reporting system: As of April 2007, pesticide companies are now required to report all health and environmental incidents associated with their products to the Government. Incident reports are being received electronically, stored in a database, and posted online. Page 10

Activities under the Food and Drugs Act Will undertake the health and environmental assessments of more than 9,000 substances used in products regulated under the Food & Drugs Act Work with stakeholders to promote best practices for the proper disposal of Food & Drugs Act products, such as pharmaceuticals and personal care products, to reduce the burden on the environment Enhanced management of environmental contaminants in food –The regulation of contaminants under the Food and Drug Regulations will be strengthened. –Actions will be taken to identify and reduce these contaminants in the food supply and to minimize potential health impacts on Canadians. –Consumers will be provided with up-to-date food safety information to help them make healthy food choices for themselves and their families Page 11

External Advisors CMP Stakeholder Advisory Council Focus on the program implementation of the CMP It allows stakeholders to provide advice and input to Government on the implementation of the CMP It fosters dialogue on issues pertaining to the CMP between stakeholders and government, and among different stakeholder groups. First meeting took place on January 18, 2008 and the summary of the meeting will be posted on the Chemical Substances website. Challenge Advisory Panel To review the application of the precautionary principle and weight of evidence The Panel provide third-party advice from distinguished, knowledgeable, and experienced individuals for science-based regulatory decision-making. Panel members serve as knowledgeable individuals in their own right; they will not represent their firms, organizations, professions, or affiliations. Decision-making will remain the responsibility of the Government. First meeting took place in December Page 12

International Regulatory Cooperation Objective: Collaboration, where appropriate, to accelerate and strengthen national, regional and global chemical assessment and management efforts Mechanisms: Trilateral Regulatory Cooperation framework (Leaders’ Summit): –strengthen the regional management of chemicals, as well as the exchange of information and knowledge –complement on-going SMOC activities Canada-EU Regulatory Cooperation Roadmap –Preliminary discussions with EU initiated to examine opportunities for technical cooperation and sharing of information Involvement in OECD to exchange information, develop evaluation methods and share the work burden Page 13

Contact Information Chemical Substances Web Site: Hotline and mailbox for the Challenge Program: DSL Surveys Coordinator Existing Substances Program Place Vincent Massey, 20th Floor 351 Saint Joseph Boulevard Gatineau QC, Canada K1A 0H3 Phone: / Fax: / Page 14

Annex - Anticipated Deadlines for Batches 1-5 of the Challenge Activity Batch 2Batch 3Batch 4Batch 5 Batch releaseFeb 3, 2007May 12, 2007Aug 18, 2007Nov 17, 2007Feb 16, 2008 End of 6 month call for informationAug 5, 2007Nov 13, 2007Feb 19, 2008May 16, 2008 Aug 15, 2008 Publication of Draft SAR and RM scope discussion documentsJan 19, 2008May 17, 2008Aug 23, 2008Nov 15, 2008Feb 14, 2009 Publication of Final SAR and proposed RM approachJuly 5, 2008Nov 22, 2008Feb 21, 2009May 16, 2009 Aug 15, 2009 Page 15