Understanding BiosafetyUnderstanding BiosafetyThe concept of biosafety encompasses a range of measures, policies and procedures for minimizing potential risks that biotechnology may pose to the environment and human health.

Establishing credible and effective safeguards for GMOs is critical for maximizing the benefits ofbiotechnology while minimizing its risks.

Unit ObjectivesUnit Objectives1. Explain the scope and intention of the

Cartagena Protocol2. Distinguish between the categories of

Living Modified Organisms ( LMOs)3. Discuss the trans-boundary Movements of

LMOs4. Illustrate the Advance informed

agreement (AIA) procedure5. Refer to the Biodiversity Clearing House6. Determine the role of Customs and border

control in implementing the CBD Protocol

Unit Outline Unit Outline

1. Introduction2. Scope and Intention of Cartagena

Protocol3. Categories of LMOs4. Transboundary Movement of LMOs5. Advance Informed Agreement ( AIA)6. Role of Customs & Border Control7. Conclusion

Scope of the Cartagena Scope of the Cartagena Protocol Protocol

The Cartagena Protocol on Biosafety is an international treaty that seeks to protect biological diversity from the risks posed by living modified organisms (LMOs), also often referred to as genetically modified organisms (GMOs), which are a product of modern biotechnology.

The Protocol is a supplementary agreement to the Convention on Biological Diversity.

Purpose of the Biosafety Purpose of the Biosafety ProtocolProtocol

Contribute to ensuring the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the conservation & sustainable use of biological diversity, taking also into account risks to human health

* In accordance with the precautionary approach* Focuses specifically on trans-boundary movements

On 29 January 2000, the Conference of the Parties to the Convention on Biological Diversity adopted a supplementary agreement to the Convention known as the Cartagena Protocol on Biosafety.

The Protocol entered into force on 11 September 2003, ninety days after the deposit of the fiftieth instrument of ratification.

Currently 163 parties to the Protocol

Status of ProtocolStatus of Protocol

Status of Ratification in the Status of Ratification in the CaribbeanCaribbean

Parties to the Protocol from the region:

Antigua and Barbuda, Bahamas,

Barbados, Belize, Cuba, Dominica,

Dominican Republic, Grenada, Guyana,

Haiti, Saint Kitts and Nevis, Saint Lucia,

Saint Vincent and the Grenadines,

Suriname, Trinidad and Tobago

Definition of LMODefinition of LMO

A living modified

organism (LMO) is any

living organism that

possesses a novel

combination of genetic

material obtained

through the use of

modern biotechnology.

Also frequently referred to as genetically modified organisms (GMOs)

Categories of LMOsCategories of LMOs

LMOs for intentional introduction into the environment (e.g. seeds, live fish)

LMOs intended for direct use as food or feed, or for processing (e.g. agricultural commodities – corn, canola, cotton)

LMOs for contained use (e.g. bacteria for laboratory scientific experiment)

Categories of LMOsCategories of LMOs

These different categories of LMOs under the Protocol have different requirements for their handling, transport, packaging and identification.

Article 18 of the Protocol (& related COP-MOP decisions) set out those requirements.

Transboundary Movement Transboundary Movement ProceduresProcedures

The Biosafety Protocol regulates the

trans-boundary movement of living

modified organisms by establishing

procedures for the export and import of

these organisms and maintaining an

information exchange mechanism known

as the Biosafety Clearing-House.

Transboundary movements of LMOs intended forintentional introduction into the environment of the Party of import are subject to the advance informed agreement (AIA) procedure, which applies before the first intentional trans-boundary movement of the LMO in question.

Step 1 – Notification by ExporterStep 2 – Acknowledgement of receipt of notification by ImporterStep 3 – Decision Making

Transboundary Movement of Transboundary Movement of LMOs LMOs

Transboundary movements of LMOs-FFP are subject to the following two-step procedure:

Step 1: Informing the Biosafety Clearing-House about the final decision on domestic use.

Step 2: Decision making by a potential importing Party.

A Party may take a decision on the import of an LMO-FFP under its domestic regulatory framework.

Transboundary Movement of LMOs-Transboundary Movement of LMOs-FFP FFP

Precautionary ApproachPrecautionary ApproachThe Protocol reflects a fundamental concept known as the Precautionary Approach which means that a government may decide not to permit a particular GMO to be imported across its borders.

This is the case even if there is insufficient scientific evidence about the GMO’s potential adverse effects.

Concerns could include the risk that imports of genetically engineered foods may replace traditional crops, undermine local cultures and traditions or reduce the value of biodiversity to indigenous communities.

Precautionary Approach

Objective: Safe transfer, handling and use of LMOs

Handling, transport, packaging,

identification: -

Documentation for shipments- Standards

• Risk Assessment

• Risk Management

- Information sharing

- Awareness & participation

• Rules & procedures

Decision making

Competent National Authorities + Advisors

Customs + Competent National Authorities

Society (public + private entities)

National / Regional National / Regional MeasuresMeasures

The Ministry of Agriculture would be the government agencies mainly concerned with the importation of animals, plants and the products derived there from.

Some Caribbean States have not yet enacted legislation specifically to deal with imports or exports of LMOs /GMOs however they fall under the general requirements of the Ministry of Agriculture.

Customs must receive either a Phyto-santitary certificate or other permit before releasing such consignments

Case StudyBiosafety Issues for

BelizeRead the document provided and

discuss in small groups with the aim of

identifying some of the challenges to be

overcome in the absence of specific

legislation to deal with the import of

LMOs /GMOs in some member states of

CARICOM/ CARIFORUM

The Role of Customs OfficialsThe Role of Customs Officials

In implementing the Biosafety Protocol customs officials are required to:Ensure LMO imports have prior approval (decisions)Ensure LMO shipments are accompanied with proper documentationVerify that contents of shipments match accompanying documentationDetect illegal LMO importsTake appropriate measures

These information requirements can be provided in different types of documentation such as:

A commercial invoice;A document required or utilized by existing documentation systems; orOther documentation as required by domestic regulatory/administrative frameworks

The Role of Customs Officials

The Role of Customs OfficialsThe Role of Customs Officials When a shipment of LMOs arrives at a port of entry, the role of customs is to:

1. Verify if shipment has proper import approvals & if there are any conditions on its import

◦This information can be obtained from Competent National Authority & BCH

2. Verify that documentation is complete

3. Ensure that contents of shipment correspond to information in accompanying documentation

◦Follow national procedures on sampling & detection

The Role of Customs OfficialsThe Role of Customs Officials

When a shipment of LMOs arrives at a port of entry, the role of customs is to (cont.):

4 a. Admit shipment to country if import of LMO has been approved & documentation is complete

OR 4 b. Follow domestic rules and procedures for refusing import if import of LMO has not been approved and/or documentation is incomplete

The Role of Customs OfficialsThe Role of Customs Officials

Other general responsibilities:Regular communication with

the Competent National Authority regarding LMOs arriving at the ports of entry

Forwarding LMO import documents to relevant national authorities

Detecting and alerting relevant authorities about possible illegal imports and unintentional trans-boundary movements of LMOs

SummarySummaryCartagena Protocol on Biosafety recognizes the

potential of biotechnology if developed and used with adequate safety measures

Protocol is intended to ensure safety of LMOs, not to prohibit their trade

Customs officials have a central role to play in implementation of the Protocol

Domestic regulations are key

It is important to obtain relevant information and keep abreast with new developments (see information sources below)

Contacts for Further InformationContacts for Further Information

Secretariat of the Convention on Biological Diversity

413 Saint-Jacques Street, suite 800Montreal, QuebecCanada H2Y 1N9Tel.: +1 (514) 288-2220Fax: +1 (514) 288-6588E-mail: secretariat@cbd.int

Protocol website: www.cbd.int/biosafetyBiosafety Clearing-House: bch.cbd.int

CNAs: bch.cbd.int/contacts/authorities.shtmlNFPs: bch.cbd.int/contacts/focalpoints.shtml

Unit ConclusionUnit Conclusion

• Clarify any questions

• Review Unit Objectives

• Link to next Unit on Montreal

Protocol