Background to the Cartagena Protocol on Biosafety

The Cartagena Protocol on Biosafety was adopted in January 2000 as a supplementary agreement to the Convention on Biological Diversity CBD).The CBD entered into force on 29 December 1993 and has 3 main objectives:

• the conservation of biological diversity;
• the use biological diversity in a sustainable fashion and
• the fair and equitable sharing of the benefits of biological diversity (2).

The CBD is primarily concerned with the conservation and sustainable use of biological diversity and the Cartagena Protocol on Biosafety was established pursuant to Article 19, paragraph 3 of the Convention on Biological Diversity which enabled the Parties to the CBD “to consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.”

Article 28 of the CBD mandates Parties to cooperate in the formulation and adoption of Protocols and thus pursuant to this Article and Article 19 (3), the Conference of Parties of the CBD established an Open-ended Ad Hoc Working Group on Biosafety to develop a Draft Protocol on Biosafety. The Working Group was to focus specifically on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity. The history of the Cartagena Protocol is well documented and the table below provides a brief summary of the negotiations.

The negotiations resulted in the adoption of the Cartagena Protocol on January 29, 2000 and in accordance with its Article 36 (4), the Protocol was opened for signature. The Protocol entered into force on 11 September 2003, ninety days after receipt of the 50th instrument of ratification, Article 37 (5) As of October 2009, 157 Parties have ratified and/or acceded to the Protocol (6). A Party to any protocol is a State that has consented to be bound by the treaty by signing and agreeing to be bound by the Objectives of the Treaty.

The Cartagena Protocol on Biosafety is the first multilateral international treaty dealing with the transboundary movement of living modified organisms commonly referred to as genetically modified organisms.

Table 1: The road to the Cartagena Protocol on Biosafety

Source: An Explanatory Guide to the Cartagena Protocol on Biosafety (7)

The objective of the Cartagena Protocol provides:

“In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.” Article 1 (8)

The objective of the Cartagena Protocol sets out the aim of the Protocol and has taken cognizance of the precautionary approach enshrined in Principle 15 of the Rio Declaration on Environment and Development. The Principle provides that:

“Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” (9)

The Cartagena Protocol is essentially a multilateral environmental agreement (MEA) to regulate environmental issues related to the intentional movement of living modified organisms. However, the Cartagena Protocol also deals with trade related issues and includes the safe transfer of living modified organisms between parties. The legal effect of the objective is such that where a State signs the Protocol and becomes a Party, the State should strive to conform to the Objective of the Cartagena Protocol in the ratification process by ensuring that the enacted national law contributes to an adequate level of protection.

The Cartagena Protocol does not elaborate on the issue of adequacy of protection, thus each Party has the discretion to include the standard it desires. The level of protection should ideally be set to ensure that any threats that might potentially harm the environment are minimized. The words “safe transfer handling and use” should take their ordinary meaning as they are not defined in the Cartagena Protocol (10). Parties should take cognizance of the fact that, in interpreting treaty language, the primary rule is that a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose (11).

The Primary focus of the Cartagena Protocol is the regulation of transboundary movement of living modified organisms.

Article 3 (k) of the Cartagena Protocol defines Transboundary Movement as:
“…the movement of a living modified organism from one Party to another Party, save that for the purposes of Articles 17 and 24 transboundary movement extends to movement between Parties and non-Parties” (12).
A State that has signed/acceded or ratified the Protocol is a Party to the Protocol whereas a non-party is a State that is not a Party to the Treaty. This clearly means that what is to be regulated is the movement of living modified organisms between two Parties.

Intentional transboundary movement between Parties and non-parties is regulated through Article 24 of the Protocol which provides that such movements shall be consistent with the objective of the Cartagena Protocol (13). Under the Vienna Convention of the Law of Treaties, a Protocol cannot create rights and obligations for non-parties without their consent (14) .

However, Article 38 of the Vienna Convention on the Laws of Treaties provides that a third state (non-party) can be bound by a treaty where the rule is recognized as customary rule of international law . International customary laws (15) are norms of behavior observed by numerous states over time which after a while are then considered as binding on all states as an accepted legal requirement.

A Party dealing with a non-Party has the burden to ensure that any bilateral, regional and multilateral agreements and arrangements on transboundary movements of living modified organisms are consistent with the objectives of the Protocol. Under Article 24(2) Parties are to encourage non-Parties to adhere to the Protocol and to contribute appropriate information to the Biosafety Clearing-House on living Modified Organisms released in, or moved into or out of, areas within their national jurisdictions.

Article 5 of the Protocol exempts the transboundary movement of living modified organisms which are pharmaceuticals for humans (16) . However, the exemption only applies where the transboundary movements of such organisms are addressed by other relevant international agreements or organizations such as the World Health Organization.

The right of any Party to subject any living modified organism intended for human pharmaceutical to risk assessment is left at the discretion of each Party as the exemption in Article 5 is without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to making of decisions on import (17).

Living modified organisms in transit or those destined for contained use are regulated under Article 6 of the Cartagena Protocol. LMOs in transit or those destined for contained use are exempt from the application of the Advanced Informed Agreement Procedure under the Protocol. Some provisions of the protocol do apply, such as the handling and labeling provisions in Article 18..

A Party’s right to regulate the transport of living modified organisms is still retained under the Cartagena Protocol and a Party may require notification prior to the transit. Any decision made by a Party with regard to the transit of LMOs should be provided to the Biosafety Clearing House.

For LMOs destined for contained use, the Cartagena Protocol provides that the transboundary movement of this category of LMOs shall be undertaken in accordance with the standards of the Party of Import. This means that a Party should develop regulations for LMOs destined for contained use. The Party of Import may also subject the LMO destined for contained use to risk assessment prior to any decision.

Article 17 of the Cartagena Protocol deals with the unintentional transboundary movements and emergency measures and is applicable to both Parties and non-Parties to the Cartagena Protocol (18). Legally, where an unintentional transboundary movement occurs within the jurisdiction of a Party, the Party is under an obligation to notify any affected or potentially affected States, the Biosafety Clearing-House and international organizations where appropriate. This means that where the affected or potentially affected State is not a Party to the Cartagena Protocol, it must be notified in line with principles of international customary laws.

The Advance Informed Agreement procedure (AIA) is the cornerstone of the Cartagena Protocol. The AIA procedure requires that before the first intentional transboundary movement of living modified organisms for the intentional introduction into the environment, the Party of Import must be notified of the proposed transboundary movement (19). The AIA Procedure enables a Party of Import to consent or reject the transboundary movement for the intentional release into the environment after assessing the potential risk to the environment.

The procedure for AIA is covered under Articles 7 to 10 and 12; and requires that a Party of Export shall notify in writing to a competent national authority of the Party of Import of an intentional transboundary movement (20) for the intentional release into the environment; (Art.8); the Party of Import must acknowledge receipt in writing to the notifier (Party of export) within ninety days; (Art.9) and the Party of Import shall give its decision to the notifier in writing on whether the intentional transboundary movement may proceed with or without conditions; (Art. 10.2 and 3).

Article 12 of the Protocol allows a Party to review its decision at any time in light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity regarding an intentional transboundary movement. The Article further allows a Party of Export or notifier to request for a review of decision where a change in circumstances has occurred that may influence an outcome of a risk assessment that was the basis of the decision.

Article 7 (3) further exempts the transboundary movement of living modified organisms intended for direct use as food or feed or processing from the AIA procedure. The AIA Procedure shall also not apply to living modified organisms that have been identified by the Conference of the Parties as being likely not to have adverse effects on the conservation and sustainable use of biological diversity (Article 7 (4)). So far, no LMO has been identified to be exempt under this Article by the Conference of Parties, however this Article provides for such an exemption in the future.

A Party of Import may opt to use a simple notification procedure in the case of intentional transboundary movement of living modified organisms provided that the Party ensures that adequate measures are applied in accordance with the objectives of the Protocol; (Art. 13.1 (a)). A Party of Import may also exempt imports of living modified organisms from the AIA Procedure; (Art. 13.1(b)).

The Party of Import still retains the right to subject the LMOs destined for contained use to risk assessment and to set the standards and requisite regulations. Thus each Party should ensure that it has adequate standards and regulations to ensure the safe handling of LMOs destined for contained use and for LMOs in transit as the Protocol has left the regulation of these to the discretion of the Parties. The right of the Party of Import to regulate could include an appropriate notification, transportation and handling procedures.

The Cartagena Protocol establishes a special procedure under Article 11 on the transboundary movement for living modified organisms destined for direct use as food, feed, or for processing (LMO-FFP). Examples of LMOs-FFP (21) include corn, soya bean, wheat or other grains that will be directly fed to humans or animals or used for processing. These categories of LMOs pose minimal environmental risk as they are not to be introduced to the environment. Any Party that makes a final decision regarding the domestic use; including the placing on the market of a living modified organism that may be subject to transboundary movement for direct use as food, feed, or processing must notify the Parties through the Biosafety Clearing-House within fifteen days of the decision. The Minimum information to be provided shall be in accordance with Annex II of the Protocol.

LMO-FFPs are not subject to the AIA procedure; however, a Party may make a decision on the import of LMO-FFPs based on its domestic regulatory framework so long as the domestic framework is consistent with the objectives of the Protocol. This means that under the domestic regulatory framework, a Party may require the LMO-FFPs to be subjected to advance notification and approval.

Parties have an obligation to provide to the BCH copies of any national laws, regulations and guidelines to the import of LMO-FFPs, if available; Article 11.5. Thus where a Party has based its decision on the import for LMO-FFPs based on its domestic regulatory framework the framework should be available to other Parties through the BCH. Article 11.5 of the Protocol on providing domestic regulatory frameworks to the other Parties through the BCH ensures transparency of the approval system as any Party can access the decision and the regulatory framework through the BCH.

A developing Country Party or a Party with an economy in transition which does not have a domestic regulatory framework for import of LMO-FFPs may take its decision prior to the first import of LMO-FFPs based on a risk assessment in accordance with Annex III and that the decision will be made within two hundred and seventy day; Article 11.6. The intention to use such a procedure should be declared through the BCH. This means that a Party that uses the mechanism under Article 11.6 can subject such imports through the prior notification and approval mechanism so long as the same does not contravene the objectives of the Protocol.

Article 18 of the Protocol addresses the Handling, Transport, Packaging and Identification of LMOs and requires that LMOs that are subject to intentional transboundary movement, are handled, packaged, and transported safely. The Provisions of Article 18 apply to all LMOs that are within the scope of the Protocol and include:

• LMOs destined for direct use as food, feed, or processing;
• LMOs destined for contained use;
• LMOs in transit;
• LMOs intended for intentional introduction into the environment.

Documentation requirements for the handling, transport, packaging and identification of LMOs are provided under Article 18.2. Generally, each category of LMO has different documentation requirements under the Protocol as follows:

• For LMO-FFPs, the documentation must indicate that the shipment “may contain” LMOs that are not intended for intentional introduction into the environment and should specify a contact point for further information.
• For LMOs that are destined for contained use the documentation must identify the shipment as containing LMOs and must specify any requirements for safe handling, storage, transport and use together with a contact point for further information, including the name and address of the individual /institution to whom the LMOs are consigned.
• For LMOs intended for the intentional introduction into the environment and any other LMO within the scope of the Protocol, the documentation should identify them as LMOs; specify the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use. The contact point for further information together with the name and address of the importer and exporter should also be included. A declaration that the movement conforms to the requirement of the Protocol should be included by the exporter.

“The documentation requirements are a means of identifying and tracking the transboundary movements of LMOs. They will be a key element in ensuring that Parties of Import know when they are receiving a transboundary movement of LMOs, whether for import or in transit” (22).
The Cartagena Protocol provides the minimum documentation requirements for the intentional transboundary movement of LMOs and each Party may within its domestic regulatory framework require additional information that is not included in the handling, transport, packaging and identification of LMOs requirements provided that the requirements are in line with the objectives of the Cartagena Protocol.

The Biosafety Clearing House is part of the clearing house mechanism that was established under Article 18(3) of the Convention on Biological Diversity to “promote and facilitate technical and scientific cooperation between the Parties to the CBD” and is implemented through the CBD Secretariat (23). The Biosafety Clearing-House (BCH) was established under Article 20 of the Cartagena Protocol to meet the objectives of the CBD by facilitating the exchange of scientific, technical, environmental and legal information on experiences with living modified organisms.

The BCH is to assist Parties to implement the Cartagena Protocol in particular, the BCH is to take into account the special needs of developing country Parties especially the least developed and small island developing states, as well as countries that are centres of origin and centres of diversity. The BCH will serve as a repository of information necessary for the implementation of the Protocol and will provide a means for the exchange of information between Parties as well as any other international biosafety information mechanism.

The information to be provided to the BCH include, existing national legislation, regulations and guidelines for implementing the Cartagena Protocol, as well as information required by Parties for the advance informed agreement procedure, bilateral, multilateral and regional agreements and arrangements, summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof. Final decisions on importation or release of living modified organisms should also be made available to the BCH.

As an information center, the BCH also provides access to other biosafety information exchange mechanisms such as information available on the United Nations Industrial Organization – Biosafety Information Network and Advisory Services. The effective implementation of the BCH will depend on all Parties providing all the necessary information for the implementation of the Protocol. Thus each Party should strive to ensure that it makes available to the BCH all the information that it uses in the implementation of the Protocol.