Cartagena Protocol on BiosafetyCartagena Protocol on Biosafety-Reducing the Environmental Risks of Modern -Reducing the Environmental Risks of Modern

BiotechnologyBiotechnology

Secretariat of the Convention on Biological DiversitySecretariat of the Convention on Biological Diversityhttps://bch.cbd.int/protocol/ https://bch.cbd.int/protocol/

Presentation OutlinePresentation Outline

Part 1:Part 1:What is the Protocol on Biosafety? What is the Protocol on Biosafety? Part 2:Part 2:How does the Protocol work?How does the Protocol work?Part 3: Part 3: Why is it important? Why is it important? Part 4:Part 4:Concluding RemarksConcluding Remarks

II

PART 1:PART 1:What is the Protocol on What is the Protocol on

Biosafety? Biosafety? • An An agreement between different agreement between different

countriescountries• Negotiated under the Convention on Negotiated under the Convention on

Biological Diversity (CBD)Biological Diversity (CBD)• Adopted 29 January 2000 after 4 years Adopted 29 January 2000 after 4 years

of intense negotiationsof intense negotiations• Entry into force: 9 September 2003Entry into force: 9 September 2003• 166 ratifications/ accessions166 ratifications/ accessions• 6 meeting of the governing body (COP-6 meeting of the governing body (COP-

MOP)MOP)• Next COP-MOP: Next COP-MOP: 6 - 10 October 20146 - 10 October 2014; ;

Republic of KoreaRepublic of Korea

ObjectiveObjective

To contribute to ensuring To contribute to ensuring the the safe transfer, safe transfer, handling and use of LMOshandling and use of LMOs resulting from resulting from

modern biotechnology that may have adverse modern biotechnology that may have adverse effects on the biological diversityeffects on the biological diversity, taking also , taking also

into account into account risks to human healthrisks to human health

ScopeScope

Applies Applies toto::• Transboundary movement, transit, Transboundary movement, transit,

handling and use of handling and use of allall LMOs that may LMOs that may have adverse effects on biodiversity, have adverse effects on biodiversity, taking also into account risks to human taking also into account risks to human healthhealth

Exclusion:Exclusion:• Pharmaceuticals for humans that are Pharmaceuticals for humans that are

addressed by other international addressed by other international agreements or organisationsagreements or organisations

For millennia, farmers have selected and saved For millennia, farmers have selected and saved their best seeds and animals for breeding so their best seeds and animals for breeding so that future varieties and breeds would have that future varieties and breeds would have

better qualities in terms of size, taste, better qualities in terms of size, taste, growth rate or yield. growth rate or yield.

In recent years, new techniques, referred to as In recent years, new techniques, referred to as modern biotechnology, have allowed modern biotechnology, have allowed

scientists to modify plants, animals and scientists to modify plants, animals and microorganisms at rates faster than those microorganisms at rates faster than those

of conventional methodsof conventional methods

They can extract genes from one organism and They can extract genes from one organism and inserting them into another, resulting in inserting them into another, resulting in

living modified organisms (LMOs)living modified organisms (LMOs)

Modern biotechnology promises to improve Modern biotechnology promises to improve human wellbeing, for example, by human wellbeing, for example, by

enhancing agricultural productivity enhancing agricultural productivity

However, there are concerns about the However, there are concerns about the potential risks that LMOs may pose to potential risks that LMOs may pose to

biological diversity and to human healthbiological diversity and to human health

Environmental Environmental concernsconcerns (examples) (examples)• Impacts on non-target organismsImpacts on non-target organisms• Transfer of genes from cultivated species to wild relativesTransfer of genes from cultivated species to wild relatives• Potential to become super weedsPotential to become super weeds• Ripple effects within ecosystems – difficult to predictRipple effects within ecosystems – difficult to predict

Health Health concernsconcerns (examples) (examples)• Potential allergenicity Potential allergenicity • Antibiotic-resitanceAntibiotic-resitance

Categories of LMOsCategories of LMOs

• LMOs for intentional introduction into LMOs for intentional introduction into the environment (the environment (such assuch as seeds and live seeds and live fish)fish)

• LMOs intended for direct use as food, LMOs intended for direct use as food, feed or processing, LMOs-FFP (feed or processing, LMOs-FFP (such as such as agricultural commodities – corn, canola agricultural commodities – corn, canola and cotton)and cotton)

• LMOs for contained use (LMOs for contained use (such as such as bacteria for laboratory scientific bacteria for laboratory scientific experiment) experiment)

PART 2: PART 2: How does the Protocol work?How does the Protocol work?

The Protocol establishes rules and procedures to regulate The Protocol establishes rules and procedures to regulate the movements of LMOs from one country to another the movements of LMOs from one country to another

Some of the measures include:Some of the measures include:

• Risk Assessment –scientific, case by caseRisk Assessment –scientific, case by case• Safe handling, transport, packaging and proper identification of LMO Safe handling, transport, packaging and proper identification of LMO

shipmentsshipments• Information sharing through Biosafety Clearing-House (BCH)Information sharing through Biosafety Clearing-House (BCH)• Capacity-BuildingCapacity-Building• Public Awareness and participationPublic Awareness and participation• Compliance procedures and mechanismsCompliance procedures and mechanisms• Liability and redressLiability and redress

Precautionary Precautionary ApproachApproach

Objective: Safe Transfer, Handling and Use Objective: Safe Transfer, Handling and Use of LMOsof LMOs

Biosafety Clearing-House (BCH) , Capacity-Building, Biosafety Clearing-House (BCH) , Capacity-Building, Compliance and COP-MOPCompliance and COP-MOP

Supporting Mechanisms:Supporting Mechanisms:

• Risk Risk AssessmentAssessment

• Risk Risk ManagemeManageme

nt nt

•InformatioInformation Sharingn Sharing

•Public Public Awareness Awareness

& Public & Public ParticipatioParticipatio

nn

• Rules/ Rules/ Procedures:Procedures:

- AIA - AIA ProcedureProcedure

- Procedure - Procedure for FFPfor FFP

• Decision -Decision -makingmaking

•Handling, Handling, Transport, Transport,

Packaging and Packaging and Identification:Identification:

- - Documentation Documentation for Shipmentfor Shipment- Standards- Standards

Key Provisions of the ProtocolKey Provisions of the Protocol

Procedures for Transboundary Procedures for Transboundary Movements of LMOsMovements of LMOs

• There are two key There are two key procedures:procedures:

– The Advance Informed Agreement (AIA) The Advance Informed Agreement (AIA) procedureprocedure

– Procedures for LMOs intended for direct Procedures for LMOs intended for direct use as food, feed or for processing (LMOs-use as food, feed or for processing (LMOs-FFP)FFP)

AIA Procedure:AIA Procedure:

-NotificationNotification

-AcknowledgementAcknowledgement

-Decision based onDecision based on

-Risk AssessmentRisk Assessment

Possible Transboundary Movement of LMOsPossible Transboundary Movement of LMOsPossible Transboundary Movement of LMOsPossible Transboundary Movement of LMOs

FFP Procedure:FFP Procedure:

-Approval for domestic useApproval for domestic use

-Import decision under Import decision under domestic framework or Risk domestic framework or Risk assessment/ Annex IIIassessment/ Annex III

For intentional For intentional release into release into environmentenvironment

For food, feed or For food, feed or processing (FFP)processing (FFP)

Final Final DecisionDecision

- Public - Public ParticipationParticipation

- Socio-Economic - Socio-Economic ConsiderationsConsiderations

Transboundary Transboundary Movement if Movement if approvedapproved

Requirements for safe Requirements for safe handling, transport, handling, transport, packaging and packaging and documentationdocumentation

MonitoringMonitoring

Review of Review of DecisionDecision

Risk ManagementRisk Management

New New informationinformation

Key proceduresKey procedures

BCHBCH

PART 3:PART 3:Why is it important? Why is it important?

The Protocol is a key agreement contributing to The Protocol is a key agreement contributing to biodiversity conservation and sustainable biodiversity conservation and sustainable

developmentdevelopment

Biodiversity is the basis of human wellbeing Biodiversity is the basis of human wellbeing

As biodiversity declines, so too does the Earth’s As biodiversity declines, so too does the Earth’s capacity to support human lifecapacity to support human life

All humanity must safeguard biodiversity from All humanity must safeguard biodiversity from all threats and to stop or reduce its lossall threats and to stop or reduce its loss

PART 4: PART 4: Concluding remarksConcluding remarks

• Several LMOs have been placed on the Several LMOs have been placed on the marketmarket

• It is important to ensure LMOs have no It is important to ensure LMOs have no negative effects on biological diversity and negative effects on biological diversity and human healthhuman health

• The Protocol establishes procedures and The Protocol establishes procedures and mechanisms for doing somechanisms for doing so

• The CPB recognises the potential of The CPB recognises the potential of biotechnology if developed and used with biotechnology if developed and used with adequate safety measuresadequate safety measures

• Biosafety is concern for all humanity. Every Biosafety is concern for all humanity. Every individual has a responsibility and a role to individual has a responsibility and a role to play in ensuring that LMOs do not adversely play in ensuring that LMOs do not adversely affect biodiversity and human health. affect biodiversity and human health.

Biosafety is concern for all humanityBiosafety is concern for all humanity

Every individual has a responsibility and a role Every individual has a responsibility and a role to play in making sure that living modified to play in making sure that living modified

organisms do not negatively impact organisms do not negatively impact biodiversity and human health biodiversity and human health

Contacts for Further InformationContacts for Further Information

Secretariat of the Convention on Biological DiversitySecretariat of the Convention on Biological Diversity413 Saint-Jacques Street, suite 800413 Saint-Jacques Street, suite 800

Montreal, QuebecMontreal, QuebecCanada H2Y 1N9Canada H2Y 1N9

Tel.: +1 (514) 288-2220Tel.: +1 (514) 288-2220Fax: +1 (514) 288-6588Fax: +1 (514) 288-6588

E-mail: secretariat@cbd.intE-mail: secretariat@cbd.int

Protocol website: Protocol website: https://bch.cbd.int/protocol/https://bch.cbd.int/protocol/

Biosafety Clearing-House: Biosafety Clearing-House: http://bch.cbd.int/ http://bch.cbd.int/