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

UNEP-GEF DEMONSTRATION PROJECTS ON

IMPLEMENTATION OF NATIONAL BIOSAFETY FRAMEWORKS

Arhus GMO Working Group 24 March 2004 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)

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:

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 NBFsUNEP-GEF Projects on Implementation of NBFs

Target: Main components of the NBFs “up and running”

UNEP-GEF NBF Implementation ProjectsUNEP-GEF NBF Implementation Projects

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


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


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


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


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


Monitoring - examples of support provided

Compilation of different approaches for monitoring

environmental effects

Summary of the compilation will be included in the guide


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


Handling requests for permits

Applicant

Competent Authority

Risk assessment body

Competent Authority – (draft) decision

Applicant

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?

Training handling requests

1. Administrative processing

3. Decision making

2. Risk assessment

3 steps:

Handling requests - decision documents:

* Summary of the request

* Summary of the risk assessment

* Summary of the procedure – reaction on received comments

* Decision

www.unep.ch/biosafety/implementation.htm

Documents

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