UNEPGEF DEMONSTRATION PROJECTS ON IMPLEMENTATION OF NATIONAL BIOSAFETY

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

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……. ”

National Biosafety Frameworks (NBFs) NBFs vary from country to country, but usually have a number of common components: 1. Government policy on biosafety 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

UNEP-GEF Projects on Implementation of NBFs 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 US$ per country

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

UNEP-GEF Projects on Implementation of NBFs 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 Policies on biosafety - examples of support provided: Ø Compilation of examples of policy documents • CD-ROM / UNEP-GEF Biosafety web site Ø 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 Regulatory regimes - examples of support provided Ø Expert panels to review (draft) legislation Ø Drafting implementing regulations / guidelines Ø Interim measures Ø 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 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 Enforcement - examples of support provided: Training workshops and the guide address: Ø Foundation for enforcement: legal basis, training of personnel Ø Preparations: inspection plans – prioritisation Ø Inspections: internal manuals for inspections, checklists

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

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

Handling requests for permits v Applicant v Competent Authority v Risk assessment body v Competent Authority – (draft) decision v Applicant

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

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

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

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