Cartagena Protocol on Biosafety:
description
Transcript of Cartagena Protocol on Biosafety:
Cartagena Protocol on Cartagena Protocol on Biosafety:Biosafety:
Capacity Building Projects in helping Capacity Building Projects in helping Parties meet their obligationsParties meet their obligations
Charles Gbedemah, UNEP/GEF, Nairobi, KenyaCharles Gbedemah, UNEP/GEF, Nairobi, Kenya
Training of Trainers Workshop for Regional Advisors, Bangkok, Thailand, 15 – 27 May 2006
1992: UNCED - AGENDA 21
1992: ADOPTION OF THE CBD
2000: ADOPTION BIOSAFETY PROTOCOL
2000: GEF STRATEGY ON BIOSAFETY
2001: DEVELOPMENT PROJECTS
2002: IMPLEMENTATION PROJECTS
2004: BCH PROJECTS
HISTORY
1992: UNCED AGENDA 21, CHAPTER 16
MODERN BIOTECHNOLOGY OFFERS PROMISES FOR:
SUSTANAIBALE FOOD PRODUCTION
IMPROVED HEALTH CARE
ENVIRONMENTAL PROTECTION
AGENDA 21, CHAPTER 16:
“…. MANKIND CAN ONLY THEN BENEFIT FULLY FROM A NEW TECHNOLOGY IF ADEQUATE SAFETY MECHANISMS ARE SET IN PLACE….”
1992: THE CONVENTION ON BIOLOGICAL DIVERSITY:
ART. 8.G: “IN SITU CONSERVATION OF BIODIVERSITY”>> OBLIGATION TO DEVELOP NATIONAL BIOSAFETY MECHANISMS
ART. 19.3: “HANDLING BIOTECHNOLOGY AND DISTRIBUTION OF ITS BENEFITS” >> >> CONSIDER A PROTOCOL ONCONSIDER A PROTOCOL ON BIOSAFETY BIOSAFETY
THE BIOSAFETY PROTOCOL
• 1996 – 2000: NEGOTIATIONS
• 2000 : ADOPTION
• 2003: 11th SEPTEMBER, PROTOCOL COMES
INTO FORCE.
• 1995: DECISION TO DEVELOP A PROTOCOL FOCUSING ON THE TRANSBOUNDARY
MOVEMENT OF LMOs (GMOs)
The Cartagena Protocol
I. Overview of the Protocol
II. Rights and Obligations
Cartagena Protocol on BiosafetyCartagena Protocol on Biosafety
Embrace Benefits Ensure adequate safety
A balanced approach toward Biotech
Objectives
– Objectives:Protection of biodiversity and human health
– Focus: Transboundary movements of LMOs
Scope
– Applying to:- Transboundary movement (main
focus)- Transit- Handling- Use – Exception: - Pharmaceuticals for humans covered
by other relevant international agreements or organizations
Categories of LMOs
Three categories of LMOs:
– Intentional introduction into the environment (e.g. seed for planting)
– Intended for direct use as food or feed or for processing (e.g. genetically modified corn for human consumption)
– For contained use (e.g. for laboratory use)
The Protocol Architecture Objective: Protection of biodiversity and human health
Focus: Transboundary movements of LMOs
BCH, Capacity Building, Compliance, Liability
SUPPORTING MECHANISMS
Risk Assessment
Risk Management
Info Sharing
(BCH)
• AIA Procedure
• Procedure for FFP
Handling transport packaging Identification
•documentation for shipment
Precautionary Approach
Section IIRights and Obligations
A. Two Procedures
AIA procedure
Procedural steps:
Notification (Art.8)(Exporters)
Acknowledgement(Art.9)
(Importing PartyWithin 90 days)
Decision-making(Art.10)(maximum 270 days)
Review of decision(Art.12)
AIA procedure: Application
– Application:
First intentional transboundary movement of LMOs for intentional introduction into the environment of the Party of import
– Exemption
Not to apply LMOs identified by decisions of COP/MOP (Art.7.4)
AIA procedure: Discretions
– Opt out of AIA by Applying: - Domestic framework - Art.9.2 (c)
- Simplified Procedure: Inform the BCH imports of LMOs to be exempted from AIA
(Art.13)
Conditions:
Domestic regulatory framework or adequate safety measures in place
AIA procedure: Decision-making
Decision-Making
Precaution
Risk Assessment(Basis)
Procedure for LMO-FFPs (1)
• Sharing information:
• - Informing BCH of final decisions on domestic use of LMOs within 15 days
- Providing information specified in Annex II
- Ensuring Accuracy of information• Decision-making on the import:
Subject to domestic regulatory framework
• Precaution (Art.11.8)
Procedure for LMO-FFPs (2)
Developing and EIT Parties
in the absence of domestic regulatory framework
• Risk assessment based on the Protocol• Decision making within 270 days• Silence not to imply consent or refusal
Section IIIB.
Risk Assessment Risk Management
Risk Assessment
Risk assessment - basis for decision-making
– Parties may subject all LMOs to risk assessment prior to decisions on import
– How to conduct
- In a scientifically sound manner- In accordance with a technical annex of
the Protocol (Annex III)
Risk Management
Establish strategies and mechanisms to regulate and control risks of LMOs identified in the risk assessment (Art.16)
Section IIC.
Handling, TransportPackaging and Identification (Art.18)
Article 18
General Obligations:
• Take measures to ensure LMOs handled, packaged and transported under conditions of safety
Specific Obligations:
• Require documentation for shipment of LMOs - identification
Documentation Requirements
• Identification of LMOs - LMO-FFP: “May contain”
- LMO for introduction into the environment: Clear identification/Declaration of conformity with the Protocol
- LMO for contained use:clear identification/requirements for
safe handling
Current MOP 3 Issue, Curitiba, Brazil, 13 – 17th March 2006
• Handling,transport, packaging and identification (Art 18)
• Risk Assessment and risk management: (Art 15 & 16)
• Liability and redress (Art 27)• Subsidiary bodies (Art 30)• Monitoring and reporting (Art 33)• Assessment and Review (Art 35)
Decision of COP-MOP 3
• Adopted a decision that requires clear and detailed identification requirements
for shipments LMO-FFPs
• A two-stage approach is set out for cases where the identity of the LMO shipment is not known
Decision of COP-MOP 3
•Where the identity of the LMO is known through “means such as identity preservation systems”, the shipment must be identified as one that “contains” LMOs that are for direct use as food or feed, or for processing
Decision of COP-MOP 3
• Where the identity of the LMO is not known through “means such as identity preservation systems”
the shipment can be identified as one that
“may contain” one or more LMOs This requirement is subject to review and
assessment at the 5th Meeting of the Parties (2010), “with a view to considering a decision” at the 6th Meeting of the Parties (2012) to ensure that the shipment “contains” LMO-FFPs.
(4-6 years interim period)
Decision of COP-MOP 3
• Both case: the documentation accompanying them must include the following details:
- that the LMOs are not intended for intentional introduction into the environment
- the common, scientific and, where available, commercial names of the LMOs
- the transformation event code of the LMOs or, where available, as a key to accessing information in the Biosafety Clearing House (BCH), its unique identifier code
- the internet address of the BCH for further information
Decision of COP-MOP 3
• “transformation event code”, which distinguishes between the different transgenic lines
• Some LMOs have a “unique identifier code” which acts as a key to accessing full information about the LMO in a database.
• The BCH is a publicly accessible internet based database which is administered by the Secretariat of the Convention on Biological Diversity which provides some information about LMOs, and is part of the implementation of the Biosafety
Section IID.
Information Sharing
Information Sharing
Obligation to submit the Information to BCH
• National Law and regulation• Bilateral/Regional/Multilateral Agreements• Summaries of Risk Assessment• Decisions on importation and release of LMOs • National reports• Decisions under AIA and Article 11 procedures• Contact details for CAN, NFP and emergency
contacts
Public Participation
• Promote public awareness and education
• Facilitate public access to BCH• Consult the public in decision-making• Make result of decisions available
MOP Decision:MOP2 considered options of
cooperation and implementation
Section IIE.
Other Provisions
Socio-Economic Considerations
In reaching decisions on import of LMOs:
• May take into account socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biodiversity, especially with regard to the value of biodiversity to indigenous and local community
• Consistent with Parties’ international obligations
MOP Decision
Decision BS-I/12
MOP 2 considered:
Cooperation on research and information exchange on any socio-economic impacts of LMOs, especially on indigenous and local communities
Questions ? and Answers
Dev ProjectDev ProjectDev ProjectDev Project
ProtocolProtocolProtocolProtocol
ToolsToolsToolsToolsImp. P
roject
Imp. P
roject
Imp. P
roject
Imp. P
roject
Obligatio
Obligationsns
Obligatio
Obligationsns
BCH Project
BCH Project
BCH Project
BCH Project
????
????????????
Country Process for Meeting the Country Process for Meeting the Obligations under the Cartagena Obligations under the Cartagena
Protocol Protocol
Question !
What are Parties doing to meet these obligations? (2 step approach)
•Draft NBF with the following 5 common components
•Integrate the NBFs into their national systems
National National Biosafety Framework Biosafety Frameworkss
key componentskey components1.Biosafety Policy2.Regulatory regime3.System to handle requests
(administrative, risk assessment & management, decision making)
4.Follow up activities (enforcement, monitoring for environmental effects)
5.Public Awareness and Participation
GEF Initial Strategy on Biosafety,
2000 ACTIVITIES OF GEF INITIAL STRATEGY
1. A project to assist in developing National Biosafety Frameworks (NBFs)
2. A limited number of demonstration projects to assist in implementing the National Biosafety Frameworks;
3. Support for countries to participate in the Biosafety Clearing House
4. Coordination with other organizations to provide biosafety-related assistance
5. Enhancement of scientific and technical advice to GEF on biosafety issues
UNEP-GEF Projects for National Biosafety UNEP-GEF Projects for National Biosafety FrameworksFrameworks
3. Implementation Projects
1. Development of NBFs
2. BCH Project
……Up to 130 Up to 130 countries countries
developing an NBFdeveloping an NBF
……Up to 139 Up to 139 countriescountries
… … 8 Demonstration 8 Demonstration Projects on Projects on
Implementation of NBFImplementation of NBF
UNEP-GEF Development of NBFs
Dates: Started June 2001 and ending December 2006
Duration: National projects average 24 months
Total cost: $36 million from the GEF, plus co-financing of $12 million from UNEP and participating countries.
Participants: Up to 130 countries – Each country budget of between 100,000 to 200,000 US $ plus 50% in additional co-financing from country
GEF Initial Strategy on BiosafetyGEF Initial Strategy on Biosafety
FROM: the initial country status TO: an advanced draft NBF ready for process in government
1. Development Phase
2. Implementation Phase
FROM: a draft or approved NBF
TO: a fully operational NBF
Suggested Country Road Map for the Suggested Country Road Map for the development ofdevelopment of
National Biosafety Framework (NBF)National Biosafety Framework (NBF)
Establish project
management structures
Surveys of:
• Existing capacity building programmes • Current status of biotechnology• Existing legislation• Regional mechanisms for harmonisation• Other issues as identified by country• National expertise in relevant fields
National workshop for stakeholders to:
review findings, identify gaps and needs, and to decide priorities for
NBF
Stakeholder workshops
to identify key components of NBF and discuss final draft
Prepare draft of National Biosafety
Framework
Training workshopson different NBF components as required
Awareness workshops for target groups
Roster of national experts
Tools for Development of NBFs
1. Regional Coordinators give support to countries
2. Training to help financial and project management
3. Toolkits help guide through Phases of the Project
4. Workshops help to build capacity
5. Meetings provide opportunity to build networks
6. Technical advice made available to countries
7. Promotion of cooperation with all other relevant organizations, countries, etc
8. Information needs serviced from central point
Legislation Surveys: Gaps identifiedLegislation Surveys: Gaps identified
•Lack of primary legislationLack of primary legislation
•Existing legislation not having enforcement Existing legislation not having enforcement mandatesmandates
•Statutes not “LMO issue sensitive” or Cartagena Statutes not “LMO issue sensitive” or Cartagena Protocol compliantProtocol compliant
Provide useful guidelines in the elaboration of the relevant Provide useful guidelines in the elaboration of the relevant legislation on Biosafety.legislation on Biosafety.
•Challenge for countriesChallenge for countries
•Modify existing legislationModify existing legislation•A new legislation as part of existing oneA new legislation as part of existing one•A new legislation entirelyA new legislation entirely
Administrative Systems GapsAdministrative Systems Gaps
Need for competent Need for competent authority/authoritiesauthority/authorities
Institutional arrangements for Institutional arrangements for permitspermits
Operational modalities of the Operational modalities of the authorityauthority
Enforcement arrangementsEnforcement arrangements
Lack of national database (BCH)Lack of national database (BCH)
UNEP-GEF Biosafety Projects
3. Implementation Projects1. Development of NBFs
2. BCH Project
126 countries developing 126 countries developing an NBFan NBF
……Up to 139 countries to Up to 139 countries to help use and access BCHhelp use and access BCH
… … 8 demonstration 8 demonstration projects (out of 12) on projects (out of 12) on Implementation of NBFImplementation of NBF
Development of NBFs :pilot enabling activities in 18 countriesDevelopment of NBFs :pilot enabling activities in 18 countries
Addresses national priorities
Country-driven & managed
Meet CPB country’s
obligations
Main project characteristics
Implementation Phase Issues to Implementation Phase Issues to consider:consider:
Objective 1:Objective 1: To integrate Biosafety and Biotechnology into national To integrate Biosafety and Biotechnology into national and development plans (Policy)and development plans (Policy)
Some possible outcomes (activities dev to meet outcomes):Some possible outcomes (activities dev to meet outcomes):
• Biotechnology and biosafety recognized as a sustainable Biotechnology and biosafety recognized as a sustainable development issue in NBSAP, NEAP and Biotechnology and development issue in NBSAP, NEAP and Biotechnology and Biosafety Strategy and Action PlanBiosafety Strategy and Action Plan
• Strengthened political and public support for Strengthened political and public support for biotech/biosafety policybiotech/biosafety policy
• Enabling mechanisms to adapt policy to changing needsEnabling mechanisms to adapt policy to changing needs
Implementation Phase Issues to Implementation Phase Issues to consider: (cont’d)consider: (cont’d)
Objective 2:Objective 2:
To establish a fully functional and responsive regulatory To establish a fully functional and responsive regulatory regime in line with CP and national needs on biosafetyregime in line with CP and national needs on biosafety
Some possible outcomes (activities dev to meet outcomes):Some possible outcomes (activities dev to meet outcomes):
• Regulatory regime in place that is consistent with CP and Regulatory regime in place that is consistent with CP and other domestic and international obligations other domestic and international obligations
• Regulatory regime published and made accessible to all Regulatory regime published and made accessible to all stakeholders stakeholders
• Application and enforcement of the regulatory regime Application and enforcement of the regulatory regime
Implementation Phase Issues to Implementation Phase Issues to consider: (cont’d)consider: (cont’d)
Objective 3:Objective 3: To have fully functional national system for handling To have fully functional national system for handling requests and applicationsrequests and applications
Some possible outcomes (activities dev to meet Some possible outcomes (activities dev to meet outcomes):outcomes):
• Establishment of a fully functional and workable Establishment of a fully functional and workable system for handling applications, their system for handling applications, their consideration and decision makingconsideration and decision making
• A fully functional decision-making systemA fully functional decision-making system
• A fully functional administrative systemA fully functional administrative system
• A fully functional system for handling, storing and A fully functional system for handling, storing and exchanging information including the use of the BCHexchanging information including the use of the BCH
Implementation Phase Issues to Implementation Phase Issues to consider: (cont’d)consider: (cont’d)
Objective 4:Objective 4:
To set up a workable and fully functional system for To set up a workable and fully functional system for monitoring and enforcementmonitoring and enforcement
Some possible outcomes (activities dev to meet Some possible outcomes (activities dev to meet outcomes):outcomes):
• Establishment of roles and responsibilities for Establishment of roles and responsibilities for monitoring and enforcement monitoring and enforcement
• Strengthen systems for enforcementStrengthen systems for enforcement
• Emergency response procedures established and Emergency response procedures established and operationaloperational
Implementation Phase Issues to Implementation Phase Issues to consider: (cont’d)consider: (cont’d)
Objective 5:Objective 5: To establish a fully functional systems for: Public To establish a fully functional systems for: Public awareness, Education, Participation, Access to awareness, Education, Participation, Access to information information
Some possible outcomes (activities dev to meet Some possible outcomes (activities dev to meet outcomes):outcomes):
• National system for access and sharing of National system for access and sharing of informationinformation
• Strengthen system for public awareness and Strengthen system for public awareness and educationeducation
• Strengthen system for public participation in Strengthen system for public participation in decision-makingdecision-making
UNEP-GEF Biosafety Projects
1. Development of NBFs
2. BCH Project
120 countries 120 countries developing an NBFdeveloping an NBF
……Up to 139 countries to Up to 139 countries to help use and access BCHhelp use and access BCH
3. Implementation Projects
… … 8 demonstration 8 demonstration projects (out of 12) on projects (out of 12) on Implementation of NBFImplementation of NBF
Background
• Project developed as direct response to country needs for access and use of the BCH;
• Developed in collaboration with the SCBD; and
• Fits within the GEF Initial Strategy for assisting countries to prepare for entry into force of the Cartagena Protocol.…. to support activities for countries to participate in BCH, once the terms of reference are agreed.
Project Objectives
• To develop core human resources in use and access of BCH in countries;
• Establish an appropriate national BCH infrastructure to enable eligible countries to fully participate in, and benefit from, the Biosafety Clearing-House (BCH).
BCH Regional Advisors
• BCH Regional Advisors will:– Assist countries in making choice for
type and style of national participation in the BCH;
– Deliver training activities, with national counterparts, in the use and access of the BCH; and
– Assist in making choice of national participation in the BCH operational.
Objective: Establish Appropriate National BCH Infrastructure
• Support for:– Making a choice for national
participation in the BCH;– Purchase and set up of equipment
required for the national BCH; • Collaboration with Governments of:
– Canada;– Switzerland; and– USA
Regional BCH
• Some countries have requested a regional BCH structure that would allow country web presence, and reduce maintenance problems;
• UNEP-GEF Biosafety team is exploring with different donor governments the possibilities to create regional BCHs;
• With Environment Canada’s assistance there is a project under way for the Pacific island countries.
www.pub.ac.za
Questions ? and Answers
Dev ProjectDev ProjectDev ProjectDev Project
ProtocolProtocolProtocolProtocol
ToolsToolsToolsToolsImp. P
roject
Imp. P
roject
Imp. P
roject
Imp. P
roject
Obligatio
Obligationsns
Obligatio
Obligationsns
BCH Project
BCH Project
BCH Project
BCH Project
????
????????????
THANK YOU !THANK YOU !