Understanding Biosafety
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Transcript of Understanding Biosafety
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: [email protected]
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