Cartagena Protocol on Biosafety: Capacity Building Projects in helping Parties meet their...

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


•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


• 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)


• 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


• “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

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Obligatio

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BCH Project

BCH Project

BCH Project

BCH Project

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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


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


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


• 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


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


• 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

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roject

Imp. P

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roject

Obligatio

Obligationsns

Obligatio

Obligationsns

BCH Project

BCH Project

BCH Project

BCH Project

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THANK YOU !THANK YOU !

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