1. ENVR 401 December 1, 2003 Supervisor: George McCourt Ashleigh Akalehiywot Andrea Hicks Mara Dacso Ted Walker Lillian Harris Kate Washington Regulation of Biopharmaceuticals in Canada

2. Presentation Outline  Client  Context of Research  Research Question  Methodology  RSC Recommendations  Government Response  Analysis  Comparative Studies  Conclusion  Suggestions to Client

3. Polaris Institute - Ottawa Biojustice Project, Lucy Sharratt  Canadian regulatory system  Plants with Novel Traits - Biopharmaceuticals  Environmental risks of biopharming

4. Context of Research Regulatory Bodies  Canadian Food Inspection Agency  Environment Canada  Health Canada

5. Context of Research  Dir94-08 and Dir2000-07 biotechnology directives  Royal Society of Canada report  Action Plan and Progress Reports  Interim Amendments to Dir2000-07

6. Research Question Do the most recent Federal Government regulations on Plants with Novel Traits take into consideration the Royal Society of Canada Report’s recommendations concerning environmental risks of field testing?

7. Interim Amendments Directive 2000-07 Action Plan & Progress Reports RSC (2001) Government Legislation Non-government Risk assessment Government Mandate

8. Methodology  Selected recommendations for analysis  Assessed government's response: Action Plan and Progress Reports  Analyzed Interim Amendments  Identified gaps in Canadian regulation  Comparative studies: United States and European Union

9. Interim Amendments Directive 2000-07 Action Plan & Progress Reports RSC (2001) Government Mandate Government Legislation Non-government Risk assessment

10. Recommendation 6.3(Effects of Selection)  potential effects of selection: on an introduced organism or on genes transferred to natural recipients Concerns: Perpetuation of transgenes within wild populations RSC Recommendations

11. Recommendation 6.6 (Reproductive Biology)  environmental assessments should pay particular attention to reproductive biology obtained from specific experiments Concerns: Gene flow

12. RSC Recommendation Recommendation 6.7 ( Greater Ecosystem Knowledge)  environmental assessments should include potential impacts on natural and disturbed ecosystems Concerns: Biodiversity; genetic diversity within populations

13. Interim Amendments Directive 2000-07 Action Plan & Progress Reports RSC (2001) Government Mandate Non-government Risk assessment Government Legislation

14. Action Plan and Progress Report Focus of Action Plan : Transparency Inspection and monitoring Harmonization of CFIA and EC regulation Although the Action Plan makes reference to specific RSC recommendations, the proposed actions and their implementation deal with the environmental concerns on a general level.

15. Action Plan and Progress Report Rec 6.3 (effects of selection)  Effects of Selection now required under New Substances Program of the CEPA Rec 6.6 (reproductive biology)  Not addressed Rec 6.7 (greater ecosystem knowledge)  Canadian Biotechnology Strategy Fund: supports relevant research projects

16. Interim Amendments Directive 2000-07 Action Plan & Progress Reports RSC (2001) Government Mandate Non-government Risk assessment Government Legislation

17. Interim Amendments Biopharmaceutical field testing Environmental safety measures:  Increased isolation distances and mandatory buffer zone  Strict disposal requirements  Increased monitoring  Contingency Plan

18. Interim Amendments Directive 2000-07 Action Plan & Progress Reports RSC (2001) Gaps

19. Identified Gaps Regulation for approval of biopharmaceuticals does not include Measures preventing risk to wild ecosystems Insufficient precaution Incentives/funds for further scientific research

20. The Reasons These gaps exist because one of the following reasons: a) Concerns not mentioned in regulation OR b) Concerns mentioned but regulation not adequate OR c) Concerns addressed through suggestions not requirements

21. Research Question Do the most recent Federal Government regulations on Plants with Novel Traits take into consideration the Royal Society of Canada Report’s recommendations concerning environmental risks of field testing?

22. Answering the Research Question The newest Canadian regulation (interim amendments) does address some additional environmental concerns as recommended by the RSC report, but key elements still missing Further research to gain empirical knowledge Greater precaution until more knowledge acquired More comprehensive regulation to prevent danger to ecosystems

23. Employs "Best Science" Framework Regulatory Bodies  U.S. Department of Agriculture - Animal and Plant Health Inspection Service  Environmental Protection Agency  Food and Drug Administration Comparative Study ~ United States

24. Biopharming in the United States  Exclusivity of farm equipment  Isolation distance vs closed-pollination  Temporal isolation

25. Based on "Precautionary Principle"  Moratorium  No field testing of biopharmaceuticals Comparative Study ~ European Union

26. Conclusions  RSC raises specific environmental concerns  Interim amendments partially reflect RSC concerns  U.S. imposes additional precautions in field testing  E.U. restricts testing of biopharmaceuticals

27. Suggestions to Client  Empirical knowledge  Effects on non-agricultural ecosystem  Restrictions on confined field testing  Explicit rather than suggestive language

28. Everybody is welcome to join us for a GMO-free beer at Hurley’s Irish Pub. First round’s on George!