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November 2009 Stakeholder Webinar

Overview of the Domestic Substances List Inventory Update and the CEPA 1999 Section 71 Notices Published on October 3 rd , 2009. November 2009 Stakeholder Webinar. Overview. Canadian Environmental Protection Act, and the DSL DSL IU Overview and objectives

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November 2009 Stakeholder Webinar

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  1. Overview of the Domestic Substances List Inventory Update and the CEPA 1999 Section 71 Notices Published on October 3rd, 2009 November 2009 Stakeholder Webinar

  2. Overview • Canadian Environmental Protection Act, and the DSL • DSL IU Overview and objectives • Considerations for substance selection • Who is required to respond? • Who do these notices apply to? • Declaration of Non-Engagement / Declaration of Stakeholder interest forms • Confidentiality • Information required • CMP eSubmissions system • Example scenarios 2

  3. The Canadian Environmental Protection Act, 1999 (CEPA 1999) • The legal framework for the Domestic Substances List resides under the Canadian Environmental Protection Act (CEPA) • History of CEPA • First passed into law in 1988 • CEPA was amended in 1999; new provisions were added • Requires the Minister of Environment to maintain an inventory of Existing Substances in Canada (Domestic Substances List). • Provides the regulatory framework and process for information collection, risk assessment and risk management of new and existing chemicals and organisms • Has provisions for assessment of existing chemicals and organisms and requires every new substance made in Canada or imported from other countries to be assessed against specific criteria • The DSL is the sole basis for determining whether a substance is new for the purposes of the CEPA, 1999. 3

  4. Collection of Information Under CEPA Pursuant to Section 71 of the Canadian Environmental Protection Act, 1999, the Minister may publish in the Canada Gazette a notice: • Requiring any person who is described in the Notice and within the period specified in the Notice engaged in any activity involving the substance to notify the Minister (71(1)(a)) • Requiring any person who is described in the Notice, to provide the Minister with any information and samples, including in respect of a substance, available toxicological information, monitoring information, samples of the substance and information on the quantities, composition, uses and distribution of the substance and products containing the substance (71(1)(b) and 71(2)(a)) 4

  5. DSL baseline data needs updating • The Domestic Substances List (DSL) was initially compiled to obtain a full list of substances in Canadian commerce (1984-’86). • Policy and Program decisions currently rely on data that is largely based on the ‘84-86 quantities and uses. • Periodic updates are also done internationally to account for changes associated with uses and quantities. 5

  6. DSL IU is key to supporting ongoing work under the CMP for chemicals • Initial Data Gathering for the CMP • In 2006, CEPA s.71 Notice gathered information on 500 high priority substances to establish assessment streams. • Since 2006, data was gathered via CEPA s.71 on batches of substances every 3 months, or in support of sector-based data collection (petroleum) • The Government is committed to taking action, via successive rounds, on all substances identified through categorization • 3000 remain from Categorization • 1250 had uncertain Categorization results • 750 deemed low concern (based on low DSL nomination quantity data) • Work will build on the lessons learned from use of the categorization data in risk assessment/management programming • Approaches to facilitate information submission and sharing have also been refined by harmonizing codes with US EPA. 6

  7. Objectives of DSL Update: Update “in commerce” status Sectors, uses and quantities For substances “in commerce”: Set priorities for risk assessment and risk management Identify themes such as: Sector-based approaches Exposure to humans by substances in certain products Substance based (e.g. brominated flame retardants) Overall hazard of specific substances Proactive Management Cross-reference trends in existing substances with those in new substances Establish sector-based or substances-based agreements International initiatives / decisions in other jurisdictions To inform the risk assessment and management of micro-organisms 7

  8. Initial collection staged over 2 years: • Initial data collection over 2 yrs; with proposed cyclical collection every 5 years • Data reporting will be tiered based on quantities being reported. • 2009: Collect data for immediate needs (based on 2008 data): • CEPA s.71 Notices online via the current CMP eSubmissions system targeting manufacturers and importers. • ~550 substances that represent a cross section of themes: • Chemicals (with volume based trigger for reporting) • Micro-organisms (Biotechnology) (first time s.71 notice) • 2010: DSL IU initial collection cycle (based on 2009 data): • Balance of substances requiring information to inform next steps (~3000) • Key Benefits: • Tiered approach provides industry time to implement data collection systems. • Gather information to support medium and long term planning purposes. • To inform the risk assessment and management activities. 8

  9. Substances included in s.71 Notice Published Oct. 3rd 2009 (Inanimate) 9

  10. Substances included in s.71 Notice Published Oct. 3rd 2009 (Inanimate) • Ecological considerations for approx. 350 substances: • Substances identified as potentially PBiT based on new data, international decisions, and their analogs. • Precursors and analogs of substances meeting at least one criterion set out in section 64 of CEPA 1999 • Substances that have been identified as high production volume (HPV) chemicals in other jurisdictions and have existing datasets, and their analogs 10

  11. Substances included in s.71 Notice Published Oct. 3rd 2009 (Animate) • Animate Substances (Organisms) • Also called ‘animate products of biotechnology’ that are currently on the DSL. • All micro-organisms on the DSL that were manufactured in or imported into Canada between 1984 and 1986 are included (45). • All are naturally occurring (not GMO). • Information collected will contribute to characterizing exposure. 11

  12. Who is Required to Respond? Persons must respond to the section 71 notices if they meet the reporting criteria specified in Schedule 2 of the notices. Respond on a company-wide basis, including information with respect to each facility in their single response on behalf of the entire company. Pursuant to s.71(1)(b) of CEPA 1999, provide information in your possession or to which you are reasonably expected to have access. 12

  13. Who do these Notices Apply to? (Schedule 2 of the Notices) The notice for inanimate substances (chemicals) applies to any person who: During the 2008 calendar year, manufactured or imported a total quantity greater than 100 kg of a substance listed in Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item. The notice for animate substances (micro-organisms) applies to any person who: During the 2008 calendar year, manufactured or imported a substance listed in Schedule 1 to this notice, whether alone, in a mixture, or in a product (any volume). 13

  14. Declaration of Non-Engagement &Declaration of Stakeholder Interest Declaration of Non-Engagement (DNE): Companies that are not involved with the substances in a section 71 notice are encouraged to submit a Declaration of Non Engagement. Declaration of Stakeholder Interest: Companies who do not meet the reporting requirements of a notice but who have a commercial interest in any of the listed substances are encouraged to identify themselves as stakeholders for the substance. Identify the substances of interest to your company and specify your activity or potential activity with the substance (ie: import, manufacture, use). You will be included in future mailings regarding these substances and may be contacted for further information regarding your activity/interest in these substances. 14

  15. Confidentiality Pursuant to section 313 of CEPA 1999, any person who provides information in response to a section 71 notice may submit with the information, a written request that it be treated as confidential. Specify the parts [e.g. sections, tables] of the information that you request be treated as confidential. Request should only be made for information that is truly confidential. Suppliers and customers can collaborate on a "blind submission“, in cases where products sold by the supplier contain substances listed in the section 71 notice and the suppliers are looking to protect their formulations as confidential business information. 15

  16. Example of Information submitted (Chemicals) 16

  17. Animate Substances (Organisms) Notice • Similar to Inanimate (Chemicals) Notice but with some differences: • No volume threshold for reporting. • Biotechnology-specific use codes. • Trade names requested. • No request for consumer and commercial codes. 17

  18. Example of Information submitted (Inanimate Substances - Organisms) 18

  19. CMP eSubmissions System What is it? An online web application for collecting chemical data under section 71 of CEPA 1999 for the CMP. Using this application respondents can submit responses to: Section 71 notices (Signed declaration must be submitted to the DSL Surveys Coordinator) Declarations of non-engagement Declarations of stakeholder interest Where is it? Links to the CMP eSubmissions system, as well as an “eSubmissions - How To Guide” are available from the Chemical Substances website: www.chemicalsubstances.gc.ca If you require assistance using the CMP eSubmissions system, please contact the DSL Surveys Coordinator: DSL.Surveyco@ec.gc.ca 19

  20. Contact information Deadline for responding to the October 3rd 2009 Notices for Micro-organisms or Chemicals: March 30, 2010, 3pm EDT, with possible 2-month extension available. Questions regarding the s.71 notices can be directed to the: DSL Surveys Coordinator Chemicals Management Plan Gatineau QC K1A 0H3 Tel: 1-800-567-1999 or 819-953-7156 Fax: 1-800-410-4314 or 819-953-7155 Email: DSL.SurveyCo@ec.gc.ca Notices and detailed guidance documents for completion of the notices are available through the Chemical Substances website: www.chemicalsubstances.gc.ca (Click on “Domestic Substance List Inventory Update” on right hand side) 20

  21. Example Scenarios Not meeting the reporting requirements of the Notices Meeting the reporting requirements of the Animate Substances (Organisms) Notice Meeting the reporting requirements of the Inanimate (chemicals) Notice 21

  22. Scenario 1: Examples of not meeting reporting requirements (Chemicals Notice) • In 2008, a company did not manufacture or import any substances listed in Schedule 1 of the Notices (either alone, in a mixture, in a product or in a manufactured item). • Complete the voluntary Declaration of Non-Engagementonline, using the CMP eSubmissions system. • In 2007, a company imported 50 kg of CAS RN 108-44-1 into Canada and exported 25kg of the substance to the USA. • Voluntarily submit the section 71 information using the CMP eSubmissions system. • Complete the voluntary Declaration of Stakeholder Interest available via the CMP eSubmissions system. 22

  23. Scenario 1: Examples of not meeting reporting requirements Animate Substances (Organisms) • In 2008, a forestry product company did not import any of the micro-organisms listed in schedule 1 but they used a listed substance for wastewater treatment on site • Complete the voluntary Declaration of Non-Engagementonline, using the CMP eSubmissions system. OR • Complete the voluntary Declaration of Stakeholder Interest available via the CMP eSubmissions system. 23

  24. Scenario 1: Examples of not meeting reporting requirements for Animate Substances (Organisms) In 2007, an academic research scientist did import Pseudomonas putida (ATCC 700369) and Pseudomonas stutzeri (ATCC 17587), both listed in schedule 1, and has since stored them in a freezer. Complete the voluntary Declaration of Stakeholder Interest available via the CMP eSubmissions system. 24

  25. Scenario 2 - Meeting reporting requirements of Animate Substances (Organisms) In 2008, a company imported 10 kg of Bacillus subtilis (ATCC 6051) into Canada for use in commercial and retail products. Was a substance listed in the Notice manufactured or imported during the 2008 calendar year? YES (imported) Is the company required to respond to the Notice? YES What must the company do? Submit information specified in Schedule 3 of the Notice using the CMP eSubmissions system. For liquid products, use the assumption that 1L = 1kg to calculate the amount in kg. 25

  26. Scenario 2 - Information submitted for Animate Substances (Organisms) 26

  27. Scenario 3 – Meeting reporting requirements of Inanimate Notice In 2008, a company manufactured a total of 1,500 kg of CAS RN 75-00-3 in Canada. Was a substance listed in the Notice manufactured or imported during the 2008 calendar year? YES (manufactured) Was the threshold for manufacture (> 100 kg) exceeded during the 2008 calendar year? YES (1,500kg) What must the company do? Submit information specified in Schedule 3 of the Notice using the CMP eSubmissions system. 27

  28. Scenario 3 - Information submitted for Inanimate Notice (Chemicals) 28

  29. Contact information Deadline for responding to the October 3rd 2009 Notices for Micro-organisms or Chemicals: March 30, 2010, 3pm EDT, with possible 2-month extension available upon request. Questions regarding the s.71 notices can be directed to the: DSL Surveys Coordinator Chemicals Management Plan Gatineau QC K1A 0H3 Tel: 1-800-567-1999 or 819-953-7156 Fax: 1-800-410-4314 or 819-953-7155 Email: DSL.SurveyCo@ec.gc.ca Notices and detailed guidance documents for completion of the notices are available through the Chemical Substances website: www.chemicalsubstances.gc.ca (Click on “Domestic Substance List Inventory Update” on right hand side) 29

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