Biosafety Protocol

Cartagena Protocol on Biosafety

• Parties to the Biosafety Protocol should be free to make their own decisions regarding the introduction of biotechnology into their national markets.
  
  
• Approval decisions should be based on scientific risk/benefit studies and the result of agreement between all stakeholders.
  
  
• Current implementation work should focus on Capacity Building.
  
  
• Existing liability laws provide sufficient protection. Biotech specific regimes are unnecessary and threaten trade and development opportunities.
  
  
• Documentation requirements for LMOs should not disrupt world trade. Existing documentation requirements are working.
  
  
• Existing risk assessment models and guidance meet needs.
  
  

The Cartegena Protocol on Biosafety (the Biosafety Protocol) is an international environmental agreement governing the movement between countries of living modified organisms (LMOs, also called genetically modified organisms, or GMOs). It came into force in 2003 under the United Nations’ Convention on Biological Diversity.

The Biosafety Protocol recognises that modern biotechnology has great potential for human well being, and aims to protect the environment and human health from any potential risks.

Background on the Biosafety Protocol

The Biosafety Protocol offers a process for harmonising national biosafety frameworks that can ensure appropriate risk assessments of biotechnology globally. The Biosafety Protocol entered into force on 11 September 2003 under the United Nations Convention on Biological Diversity (CBD), and has been ratified by 116 countries to date. It uses the term Living Modified Organism (LMO) in place of the more usual GMO.

The Biosafety Protocol requires that:

Exporters seek advanced informed agreement from importing countries before shipping LMOs intended for introduction into the environment (which means any imports of viable grain or seed).

Shipments of products that may contain LMOs - such as bulk commodities intended for direct use as food or feed, or for processing – must be labelled accordingly.

Risk assessment and other scientific, technical, environmental and legal information about LMOs is exchanged among Parties through a Biosafety Clearing House.

Signatories to the Biosafety Protocol include the European Union, most African and Asian nations, as well as Mexico, Japan and Brazil.  The world’s major exporters of agricultural products - including the USA, Canada, China, Russia, Argentina and Australia - have not ratified the Protocol.  However, to continue trading with nations that are parties to the treaty, all exporting nations will be required to comply with the Biosafety Protocol’s obligations.  Industry recognises its duty and responsibility in assuring safety of traded commodities, and will continue to campaign for fair, science-based regulations.

The Plant Science Industry and the Biosafety Protocol

CropLife International believes Parties to the Biosafety Protocol should be free to make their own decisions regarding the introduction of biotechnology into their national markets.  These decisions should be based on scientific risk/benefit analysis and be agreed between all responsible arms of government and all sections of the community - including public research organisations, academia, and industry.

Implementation of the Biosafety Protocol should focus first and foremost on capacity-building to bring all Parties into compliance (e.g. to build national capacities to conduct risk assessments and utilise the Biosafety Clearing House). It should avoid diverting resources from the protection of biodiversity.

Negotiation of an international liability & redress regime for biotechnology products is unnecessary given existing laws and would inhibit research, development and technology transfer.  A more prudent course would focus on national capacity building to create general environmental liability laws and development of any necessary new rules under the Convention on Biological Diversity.

Standard commercial and shipping documentation requirements can be modified to provide adequate information on LMOs to Parties.   The development of a new, stand-alone document will duplicate efforts and may lead to an increase in documentation errors.

The Biosafety Protocol should encourage information sharing and should utilise experience gained with existing risk assessment guidance materials and models (e.g. those developed by UNEP, OECD, EU, Canada, U.S. EPA, etc.) rather than developing new systems.

In-country capacity building to create and implement  general environmental liability laws is essential. Development of any necessary new laws should come under the Convention on Biological Diversity.

Public participation can assist Parties in complying with their obligations under the Biosafety Protocol.  International information exchange and sharing of best practices should be encouraged.  Implementation of public participation processes should be the decision of national governments.

Exchange of peer-reviewed analyses and information on both the positive and negative socio-economic impacts of biotechnology can be useful to Parties.

The Biosafety Protocol must complement and not undermine existing international obligations, such as the World Trade Organisation (WTO) and Codex Alimentarius.  It must also be flexible so that any country can respond rapidly to favourable developments in biotechnology

For more information on the Biosafety Protocol, click on this link:

- Biosafety Protocol