Biosafety Protocol


After almost five years of extensive negotiations, the Biosafety Protocol was finally adapted on 29th January, 2000 in Montreal, Canada during the resumed Session of the Extraordinary Meeting of the Conference of Parties to the Convention on Biological Diversity.

Biosafety means minimizing the potential risks to human health and the environment from the handling and transfer of living modified organisms produced through modern biotechnology. Unlike the conventional methods, genetic engineering enables the transfer of new genes from an entirely unrelated species, the vector or vehicle for this transfer usually being viruses or plasmids.

While the use of modern bio-technologies does hold promise for the benefit of mankind through higher production of food material and newer medicines for the treatment of various diseases, concerns have been raised about the potential risks which may arise from the release of transgenic and other Genetically Modified Organisms (GMOs or LMOs as they are called) developed through modern biotechnologies.

These risks include the spread of introduced traits on non-target species leading to genetic contamination, development of pest and herbicide resistance, contamination of food chains, displacement of traditional animal breeds and plant varieties, thereby causing genetic erosion. Apart from these, one school of thought also subscribes to socio-economic and ethical impact of the genetically modified organisms. For example, introduction of transgenic crops or products could replace traditional export crops which in turn could have far-reaching implications on the countries that are dependent on export of such crops for revenue.

Many countries with biotechnology industries already have domestic legislation to ensure the safe transfer, handling, use and disposal of LMOs and their products. However, there are no binding international agreements addressing situations where LMOs cross national borders.

Recognising the potential risks of genetically engineered organisms, the Convention on Biological Diversity (CBD) has addressed this issue of biosafety, as it is commonly called, in Articles 8(g), 19.3 and 19.4. The Article 19.3 specifically calls 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 (AIA), in the field of safe transfer, handling and use of any living modified organism resulting from biotechnology that may have an adverse effect on the conservation and sustainable use of biological diversity.

The second meeting of the Conference of Parties (CoP) in 1995 decided to establish an open-ended Ad-hoc Working Group to develop a protocol on biosafety through a negotiation process specifically focussing on transboundary movement of LMOs. Five meetings of the Ad-hoc Working Group were held from June 1996 to August 1998. The sixth and the last meeting of the Working Group was held in February 1999 in Cartagena, Colombia followed by an extraordinary meeting of CoP. This meeting failed to arrive at a consensus on the text of the protocol.

The Miami group consisting of USA, Canada, Australia, Uruguay, Chile and Argentina did not want to include products of LMOs and such products of the LMOs which are traded as commodities under the scope of the protocol and were opposed to the extension of AIA procedure to commodities. The developing countries wanted inclusion of commodities in the scope of protocol in order to take an informed decision about such imports based on safety considerations. They are also opposed to the exclusion of any LMO from the scope of the protocol.

The resumed session of Ex-CoP was held from 24-28 January, 2000 and the Biosafety Protocol was finally adopted on January 29. The objective of the protocol is to contribute to adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern bio-technology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focussing on transboundary movements.

Some Important Provisions of the Protocol

Scope: Article 4 provides for a comprehensive scope and applies to all Living Modified Organisms (LMOs) that may have adverse effect on the conservation and sustainable use of biological diversity. The Article as it now exists, is consistent with the Article 19(3) of CBD.

Precautionary principle: Precautionary principle has been incorporated in the preamble as well as operative provisions of the protocol (Article 10 on Decision procedure, Article 11 on Procedure for LMOs intended for direct use as food, feed or for processing and Annexure III). Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the potential adverse effects of LMOs on biodiversity will not prevent a Party to allow or prohibit imports of LMOs.

Pharmaceuticals: A separate Article on Pharmaceuticals (Article 5) which was not present in the Chairmanís text of the Cartagena draft of February 1999, has now been incorporated in the protocol. This Article gives rights to a Party to subject all LMOs to risk assessment prior to their import in respect of Pharmaceuticals for humans which have not been addressed by other relevant international agreements or organisations on the subject.

Advance Informed Agreement: The Advance Informed Agreement procedure applies to the first shipment of LMOs to be introduced intentionally into environment. The obligation is on exporter / exporting Party to give notification to importing Party. Decisions on imports will be taken in accordance with risk assessment and the precautionary principle.

Procedure of LMOs intended for direct use as food, feed or for processing LMO-FFP: The protocol provides for a separate procedure for LMOs intended for direct use as food, feed or for processing. A Party may take a decision on import of LMO-FFPs under its domestic regulatory framework based on the information made available through Biosafety Clearing house. Article 11 provides an option to developing countries to invoke precautionary principle while importing LMO-FFP.

Risk Assessment: Annexure III of the protocol describes the criteria governing the process of risk assessment. It gives Parties an option to evaluate the possible adverse effects of LMOs on the conservation and sustainable use of biodiversity taking into account risks to human health.

Liability and Redress: A system for liability and redress where the transboundary movement of LMOs may cause damage or harm to biodiversity and human health is provided. Such a system is to be worked out within four years after the protocol comes into force.

Biosafety Clearing House: The protocol provides for establishing a Biosafety Clearing House for sharing and exchange of information on LMOs including risk assessment of LMOs and their products.

Capacity Building: The importance of strengthening infrastructure and upgrading human resources in developing countries has been recognised under this Article on Capacity Building.

Public Awareness and Participation: Parties are obliged to promote and facilitate public Awareness and education concerning the safe transfer, handling and use of LMOs.

Socio-economic Consideration: In making import decisions, Parties can take into account socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biodiversity. However, this has to be consistent with their other international obligations.

A four-member Indian delegation led by a Joint Secretary, CS division of MOEF, alongwith the representatives from the Department of Biotechnology and the Ministry of External Affairs, participated in the resumed Ex-CoP. The Indian delegation played an important role in the conclusions of the negotiations.

The Ex-CoP also adopted a decision regarding the establishment of an open-ended Ad-hoc Intergovernmental Committee for the Cartagena Protocol and Biosafety (ICCP) with Ambassador Yang of Cameroon as the Chair. India and Iran have been unanimously chosen to represent Asia in the ICCP Bureau. Dr. PK Ghosh, Adviser, Department of Biotechnology has been nominated to represent India on the Bureau.

The Protocol will be open for signature at Nairobi from 15 May, 2000 to 26 May, 2000 and at the United Nations headquarters New York from 27 May, 2000 to 14 May, 2001.