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

Slides:



Advertisements
Similar presentations
Environmentally sound management of ship recycling- simple or complex? Roy Watkinson Department for Environment, Food and Rural Affairs UK Promoting Sustainable.
Advertisements

Action Plan for the Caribbean Countries. Current Situation Lack of the technical expertise required in the identification and documentation of LMOs.
EMS Checklist (ISO model)
Model Act: Proposed Provisions for a Transparent, Effective and Workable Biosafety Regulatory Framework Stanley H. Abramson, Esq. Arent Fox Kintner Plotkin.
Suzanne Davis Senior Research Officer – Jamaica Clearing-House Mechanism Natural History Division Institute of Jamaica.
INSAG DEVELOPMENT OF A DOCUMENT ON HIGH LEVEL SAFETY RECOMMENDATIONS FOR NUCLEAR POWER Milestone Issues: Group C. Nuclear Safety. A. Alonso (INSAG Member)
Regulatory Body MODIFIED Day 8 – Lecture 3.
1 Regulatory Challenges During and Following a Major Safety or Security Event Muhammad Iqbal Pakistan Nuclear Regulatory Authority Presentation at General.
PROJECT INCEPTION WORKSHOP on BIOSAFETY IMPLEMENTATION PROJECT OF EGYPT 9 – 10 July 2007.
February 2007Federal Regulatory Improvement Commission.
National Workshop on Labour Inspection and Undeclared Work Budapest, October 2009 Collaboration between the GLI EA and Other National Bodies to Address.
Cartagena Protocol on Biosafety:
Postgraduate Educational Course in radiation protection and the Safety of Radiation sources PGEC Part IV The International System of Radiation Protection.
Laboratory Biorisk Management Standard CWA 15793:2008
Cartagena protocol on Biosafety to the Convention on Biological Diversity and the International debates (COP- MOP) Stakeholders’ workshop on the Biosafety.
Basics of OHSAS Occupational Health & Safety Management System
Welcome To the Objectives Pillar Workshop Introduction Business need Target Audience - technical and professional staff who support decision maker.
IAEA International Atomic Energy Agency Overview of legal framework Regional Workshop - School for Drafting Regulations 3-14 November 2014 Abdelmadjid.
LEGAL FRAMEWORK & REGULATORY SYSTEM f or introduction of NPP into Vietnam Le Chi Dung (VARANS, Vietnam) Vienna, December 2008.
1 Inter-linkages: BCH, Parties, Capacity Building, Compliance and RA Concept Sustainability Biosafety Programme - Secretariat of the Convention on Biological.
1 DOE IMPLEMENTATION WORKSHOP ASSESSING MY EMS Steven R. Woodbury
Swedish IRRS mission 6-17 Feb 2012 IRRS lessons learned workshop – Brussels 22 nd and 23 rd January Elisabeth Öhlén and Ingemar Lund.
Module N° 8 – SSP implementation plan. SSP – A structured approach Module 2 Basic safety management concepts Module 2 Basic safety management concepts.
CERTIFICATION In the Electronics Recycling Industry © 2007 IAER Web Site - -
Second expert group meeting on Draft fiche on delegated act on the European code of conduct on partnership (ECCP) Cohesion Policy
Consultant: CMDC Joint Venture Reflections on draft Recommendations for Revision to Administrative Regulations: By Norman Sheridan, Legal & Institutional.
Main Requirements on Different Stages of the Licensing Process for New Nuclear Facilities Module 4.1 Steps in the Licensing Process Geoff Vaughan University.
THE BIOSAFETY BILL, 2007 JACARANDA HOTEL, 26 TH JULY 2007.
RIA: Communication – building credibility Aleš Pecka Department of Regulatory Reform and Public Administration Quality Ministry of Interior, Czech Republic.
SEVESO II transposition and implementation – possible approaches and lessons learned from MS/NMS SEVESO II transposition and implementation – possible.
CARTAGENA PROTOCOL ON BIOSAFETY NDA- DEAT BILATERAL MEETING 1 August 2003 Presenter : M. Mbengashe.
Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Regulatory Authority.
IAEA International Atomic Energy Agency School of Drafting Regulations – November 2014 Government and Regulatory Body Functions and Responsibilities IAEA.
International Atomic Energy Agency Roles and responsibilities for development of disposal facilities Phil Metcalf Workshop on Strategy and Methodologies.
SC18 TG5 Development of a Guidance Document for the implementation of API Specification Q2 Objective Create a guidance document for users of the API Specification.
Biosafety Clearing House Training Workshop date place.
Expert Group on Natura 2000 Management Meeting of 19 May 2011 Fact Sheet on Member State Natura 2000 Management Planning THE N2K GROUP.
Indicators for monitoring and assessing pharmaceutical situation in countries Dr. Edelisa D. Carandang Drug Action Program (DAP) Essential Drugs and Medicines.
STDF WORKSHOP ON SPS CAPACITY EVALUATION TOOLS 31 March 2008 Erie Tamale, Programme Officer Secretariat of the Convention on Biological Diversity
Visit us at E mail: Tele:
PEER REVIEW EXPERIENCE BOYKO MALINOV BULGARIA. GOAL TO ASSESS THE EXECUTION OF ALREADY AGREED OBLIGATIONS TO MAKE RECOMMENDATIONS FOR IMPROVEMENT.
UNEP-GEF Projects for National Biosafety Frameworks Århus Convention WG on GMOs Geneva, March 2004.
SEVESO II transposition and implementation: Possible approaches and lessons learned from member states and new member states SEVESO II transposition and.
Capacity Building for the implementation of the Cartagena Protocol on Biosafety by the German Development Co-operation: German Federal Ministry for Economic.
WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET TOPIC 6 CH 5 ISO MANAGEMENT RESPONSIBILITY Philippe Bauwin Medical.
M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 27 – Environment and Climate Change.
Priority Agricultural Policies and Standards to Advance Agricultural Trade and Access to Inputs Regional Feed the Future and Trade Africa Meeting
M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 27 – Environment and Climate Change.
Civil Society Participation and Contribution to the UNCAC Review Process Towards Transparency – TI National Contact Vietnam UNCAC Self Assessment Process:
process and procedures for assessments
UNECE Aarhus Convention Secretariat
, UKUMBI WA CHUO CHA TAIFA CHA UTALII, DAR ES SALAAM
Improving the Garment Sector in Lao PDR:
Nuclear and Treaty Law Section Office of Legal Affairs
Importance of Raising Public Awareness on Biotechnology
UNECE Aarhus Convention Secretariat
A Step by step guidance for permitting and inspection
WP 3 How to assess implementation of ALARA
Biotechnology and Biosafety Awareness
Nuclear and Treaty Law Section Office of Legal Affairs
Establishing the Infrastructure for Radiation Safety Preparatory Actions and Initial Regulatory Activities.
DNV experiences and viewpoints
Communication and Consultation with Interested Parties by the RB
Regulatory Cooperation Forum (RCF) - Plenary 2018
EMS Checklist (ISO model)
Generic licensing guidelines
Operationalizing Export Certification and Regionalization Programmes
Task Force on Target Setting and Reporting TFTSR
Meeting of PAP/RAC Focal Points, Split, Croatia, 8-9 May 2019
IAEA RER/9/141: Improving National Infrastructure for Safety   Regional Workshop on Regulatory Enforcement and Inspection Vilnius, Lithuania 11 September.
Presentation transcript:

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) 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 NBFs

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

Project execution: January 2003 – July ‘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:  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

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

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:  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

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

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

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