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An Overview of the New Substances Notification Regulations

An Overview of the New Substances Notification Regulations. EnviroPharm 2009 October 1, 2009. Overview. 1. CEPA 1999 and the NSNR Definition of toxic Definition of a new substance Substances that do not require notification 2. Notification Process Determining notification requirements

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An Overview of the New Substances Notification Regulations

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  1. An Overview of theNew Substances Notification Regulations EnviroPharm 2009October 1, 2009

  2. Overview • 1. CEPA 1999 and the NSNR • Definition of toxic • Definition of a new substance • Substances that do not require notification • 2. Notification Process • Determining notification requirements • Processing a notification • Post-notification responsibilities • 3. Contact Information

  3. Canadian Environmental Protection Act 1999 • Purpose of Parts 5 and 6 • To ensure that new substances are not introduced into Canada before an assessment of whether they meet Section 64 criteria • Section 64 Criteria (Toxic) • A substance that enters or may enter the environment in amounts that may pose a risk to: • The environment (such as fish or wildlife) • The environment on which life depends (such as water) • Human health

  4. New Substances Notification Regulations (NSNR) • Define/Prescribe: • Trigger quantities • Information requirements (schedules) • Administrative requirements • Assessment periods • Revised in 2005 and divided into: • NSNR (Chemicals and Polymers) • NSNR (Organisms)

  5. What is a Substance? • Substance • Any distinguishable kind of organic or inorganic matter, whether animate or inanimate. • Includes chemicals, polymers, biochemicals, biopolymers and living organisms (micro-organisms and organisms other than micro-organisms) • Exclusions from the definition of a substance • Mixtures (can contain notifiable substances) • Manufactured Items • Wastes

  6. What is a “New” Substance? • Any substance that is not listed on the • Domestic Substances List (DSL) • The DSL includes substances that were: • Nominated and met listing criteria • Notified and met listing criteria • Non-domestic Substances List (NDSL) • Still considered new, but subject to fewer requirements • Substances Search Engine: • www.ec.gc.ca/substances/nsb/search/eng/cp_search_e.cfm

  7. Substances that do not require notification under the NSNR • Substances listed on the DSL • “S” flag and “P” flag exceptions • Substances used for a purpose regulated under an Act or Regulation listed in Schedule 2 or 4 of CEPA 1999 • F&DA is not listed in Schedule 2 or Schedule 4

  8. In Commerce List (ICL) • A list of substances in F&DA regulated products known to have been in Canadian commerce between January 1, 1987 and September 13, 2001 • In Commerce List Policy: • Notification under the NSNR is not currently being requested for substances that: • Are listed on the ICL; AND • Are being imported/manufactured solely for use in products regulated under the Food & Drugs Act (F&DA)

  9. Chemicals and Polymers that do not require notification under the NSNR (Chemicals and Polymers) • Transient reaction intermediates • Impurities • Incidental reaction products • Low volume exemption • Substances occurring in nature if unprocessed • Polymers and proteins subject to the “Two Percent Rule” • Substances carried through Canada

  10. Living Organisms that do not require notification under the NSNR (Organisms) • Organisms that do not meet the definition of a living organism • Naturally occurring, indigenous plants and higher animals (unmodified) • R&D Organisms that meet the exemption criteria

  11. Notification Process • Prior to Submission • Who is required to Notify • How to Identify the Required Notification Information • Schedules under the NSNR (Chemicals and Polymers) • Schedules under the NSNR (Organisms) • Resources • Following Submission • Regulatory Review • Risk Assessment and Conclusions • Notifier Responsibilities

  12. Who is required to Notify? • Canadian Importers • Foreign Importers and Canadian Agent • Canadian Manufacturers (or the contracting Canadian company if manufactured on toll)

  13. Notification Categories (Schedules) for Chemicals and Polymers • NSNR (Chemicals and Polymers) • Uses a tiered approach • Quantity and type of required information depends on: • Substance type (bio/chemical or bio/polymer, RRR polymer) • Substance category (commercial, special category, high aquatic environmental release, significant public exposure) • NDSL status • Import and/or Manufacture quantities (triggers)

  14. Schedules: Bio/Chemicals

  15. Schedules: Bio/Polymers

  16. Notification Categories (Schedules) for Living Organisms • NSNR (Organisms) • The type and quantity of information required depends on: • Organism type (information required varies with organism characteristics) • Proposed Use (information required related to anticipated concerns about exposure)

  17. Schedules: Organisms

  18. Required Information • Includes: • Administrative, Substance Identity, Exposure and Use Information • Technical Information (environmental fate, ecotoxicity, mammalian toxicity, etc.) • Information requirements are listed in the schedules of the NSNR and in the NSN form • All required information must be provided in duplicate • Fees (do not apply to solely F&DA use substances)

  19. Your Resources for Preparinga Notification: • Guidelines for the Notification and Testing of • New Substances: Organisms • Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers, Version 2005 • Pre-notification Consultation (PNC)

  20. Notification Process

  21. Regulatory Screening Outcomes • Acknowledgement • NSN is complete, acknowledgement letter is written • Assessment period starts • Request for missing information • Minor deficiencies requested by phone, email or letter • Assessment period does not start • Rejection • File is returned due to major deficiencies • Assessment period does not start

  22. Risk Assessment Outcomes • No suspicion of meeting section 64 criteria • No suspicion of meeting section 64 criteria for the proposed use • SNAc Notice developed • Suspicion of meeting section 64 criteria • Condition • Prohibition • Ministerial Request

  23. Post-Notification Responsibilities • Re-notification prior to manufacture or import • For a significant new activity • For a purpose outside of the Schedule under which it was notified • Before exceeding a higher trigger quantity • Correction of Information • Section 70 of CEPA 1999 • Notice of Excess Quantity/ Manufacture or Import

  24. Inspection and Enforcement • EC may carry out inspections under CEPA 1999 to verify compliance with the regulations • If convicted of an offence in a court of law, possible penalties include fines and/or imprisonment (Part 10 • of CEPA 1999) • Compliance and Enforcement Policy • www.ec.gc.ca/CEPARegistry/documents/policies/candepolicy/toc.cfm

  25. Contact 1 • If you have questions concerning the NSNR for substances in products regulated under the F&DA, contact the Environmental Assessment Unit (EAU), Health Canada: • Phone: 1-866-996-9913 OR (613) 948-3591 • Email: eau-uee@hc-sc.gc.ca • Fax: (613) 946-6474 • Website: http://www.hc-sc.gc.ca/ewh-semt/contaminants/person/impact/index_e.html

  26. Contact 2 • If you have questions concerning the NSNR for substances that are not regulated under the F&DA, contact the New Substances Program, Environment Canada: • Phone:1-800-567-1999 • Email: NSN-infoline@ec.gc.ca • Fax: (613) 953-7155 • Website: www.ec.gc.ca/substances/nsb/eng/home_e.shtml

  27. Questions

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