1. UNEP-GEF DEMONSTRATION PROJECTS ON IMPLEMENTATION OF NATIONAL BIOSAFETY FRAMEWORKS Arhus GMO Working Group 24 March 2004

2. Article 2 of the Biosafety Protocol: “………Each Party shall take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol…….”

3. National Biosafety Frameworks (NBFs) 2. Regulatory regime for biosafety 3. System to handle notifications/requests for permits 4. Systems for ‘follow up’: enforcement and monitoring for environmental effects 5. Systems for public information, public awareness and public participation 1. Government policy on biosafety NBFs vary from country to country, but usually have a number of common components:

4. Participants:Currently 8 demonstration projects: Bulgaria, Cameroon, China, Cuba, Kenya, Namibia, Poland, Uganda Start:Late 2002 Duration:Average 3 years per country Budgets:From 500,000 – 1,000,000 US$ per country UNEP-GEF Projects on Implementation of NBFs

5. Target: Main components of the NBFs “up and running” UNEP-GEF NBF Implementation Projects

6. Project execution: January 2003 – July 2003 - ‘laying foundation’: - picture of existing situation - review of draft legislation - start up workshops - fine tuned work plan - summary on UNEP-GEF web site September 2003 – 2005: - execution of the work plan UNEP-GEF Projects on Implementation of NBFs

8. Policies on biosafety - examples of support provided:  Compilation of examples of policy documents CD-ROM / UNEP-GEF Biosafety web site  Chapter 1 of a guidance document on implementation of NBFs will provide a summary of the compilation: Policy documents take very different forms Biosafety policy is usually part of broader policies Broad-based stakeholder input UNEP-GEF Projects on Implementation of NBFs

9. Regulatory regimes - examples of support provided  Expert panels to review (draft) legislation  Drafting implementing regulations / guidelines  Interim measures  Training workshops and the guide address: Different levels of regulation (Acts, regulations, etc) Different types of provisions (general provisions, operational provisions, final clauses) Examples of provisions UNEP-GEF Projects on Implementation of NBFs

10. Handling requests - examples of support provided Training workshops and the guide address: 1.Administrative processing: application formats, guidance for applicants, internal manuals for processing, checklists, databases etc. 2.Risk assessment: systematic approach of risk assessment based on the Biosafety Protocol, ‘real life’ dossiers, internal manuals for risk assessment procedures 3.Decision making: formats for decision documents UNEP-GEF Projects on Implementation of NBFs

11. Enforcement - examples of support provided: Training workshops and the guide address:  Foundation for enforcement: legal basis, training of personnel  Preparations: inspection plans – prioritisation  Inspections: internal manuals for inspections, checklists UNEP-GEF Projects on Implementation of NBFs

12. Monitoring - examples of support provided  Compilation of different approaches for monitoring environmental effects  Summary of the compilation will be included in the guide UNEP-GEF Projects on Implementation of NBFs

13. Public information, awareness and participation – examples of support provided  Compilation of examples of public information and public participation  Address public participation in the training workshops on handling requests for permits UNEP-GEF Projects on Implementation of NBFs

14. Handling requests for permits  Applicant  Competent Authority  Risk assessment body  Competent Authority – (draft) decision  Applicant

15. Public participation in handling requests for permits Important aspects:  At which point in the procedure?  What form of public participation?  Confidentiality of data  How is information made available?  What is done with the input?  Who is involved?

16. Training handling requests 1. Administrative processing 3. Decision making 2. Risk assessment 3 steps:

17. Handling requests - decision documents: * Summary of the request * Summary of the risk assessment * Summary of the procedure – reaction on received comments * Decision

18. www.unep.ch/biosafety/implementation.htm