Review of the New Substances Notification Regulations (Organisms)

Discussion Document
Workshop on the Provisions Dealing with Organisms Other than Micro-Organisms

May 18, 2006

New Substances Program,
Environment Canada
Health Canada

NOTE TO READER: The substantive content of this document is for discussion purposes only, and reflects the initial perspectives of officials with the New Substances Program in Environment Canada and Health Canada. This document and its companion backgrounder were prepared by EC and HC following extensive discussions with other interested federal departments and agencies, including Agriculture and Agri-Food Canada, the Canadian Food Inspection Agency, the Department of Fisheries and Oceans, Natural Resources Canada, and the Pest Management Regulatory Agency; however, the options proposed herein do not necessarily represent the position of all those involved. It is expected that options will evolve and improve with feedback from readers.

TABLE OF CONTENTS (TOC)

• EXECUTIVE SUMMARY
• 1. BACKGROUND
• 2. OVERVIEW
  • 2.1 Objectives of the Review
  • 2.2 Scope of the NSNR (organisms) and this review
• 3. KEY ISSUES AND PROPOSED OPTIONS
  • 3.1 Key Issues
  • 3.2 Proposed Approach
• 4 NEXT STEPS
• 5 FURTHER INFORMATION
• Abbreviations
• Glossary
• Appendix 1: Annotated Bibliography of Useful Sources of information Related to new substances
• Appendix 2: Categories of Substances That Are Living Organisms That Do Not Require Notification Under The NSNR (Organisms)
• Appendix 3: Criteria Used to Assess the Options Identified by Environment Canada and Health Canada
• Appendix 4: Core Information Requirements for Proposed Schedules
• Appendix 5: Proposed Notification Scheme and Schedules under Option 2
• Appendix 6: Federal Acts and Regulations Applicable to the Environmental and Human-Health Assessment of New Substances that are Animate Products of Biotechnology