The Cartagena Protocol on Biosafety

1. Background

Article 19(3) of the CBD asked the parties to consider a protocol on the safe transfer, handling and use of living modified organisms (LMOs) resulting from biotechnology that may have adverse effects on biodiversity, and Article 8(g) required national measures to manage their risks. Negotiations stalled at Cartagena, Colombia in February 1999 because the “Miami Group” of GM-exporting countries (the US, Canada, Argentina, Australia, Chile, Uruguay) resisted controls on commodity shipments. The Cartagena Protocol on Biosafety was finally adopted at Montreal on 29 January 2000 and entered into force on 11 September 2003. India is a party. The United States is not, since it is not a party to the CBD.

2. Objective and the precautionary approach (Article 1)

In accordance with the precautionary approach in Principle 15 of the Rio Declaration, the objective is to contribute to an adequate level of protection in the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on biodiversity, taking also into account risks to human health, and specifically focusing on transboundary movements. Principle 15 states 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.

3. Key definitions (Article 3)

• Living modified organism: any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.
• Modern biotechnology: in vitro nucleic acid techniques (including recombinant DNA and direct injection into cells or organelles) or fusion of cells beyond the taxonomic family, that overcome natural reproductive or recombination barriers and are not techniques used in traditional breeding and selection.

Whether genome-edited organisms with no foreign DNA are LMOs under this definition is a live question. Some states (including India for SDN-1 and SDN-2 plants since 2022) treat them as outside GM rules; the EU has moved towards a lighter regime for certain new genomic techniques.

4. Scope

• The Protocol applies to the transboundary movement, transit, handling and use of all LMOs that may have adverse effects on biodiversity (Article 4).
• LMOs that are pharmaceuticals for humans addressed by other international agreements or organisations are excluded (Article 5).
• The advance informed agreement procedure does not apply to LMOs in transit or destined for contained use (Article 6).

5. Advance informed agreement (Articles 7 to 10)

Before the first intentional transboundary movement of an LMO for intentional introduction into the environment of the importing party (seeds for planting, live fish for release):

1. the exporter or exporting party notifies the competent national authority of the importing party in writing, with the information in Annex I (Article 8);
2. the importing party acknowledges receipt within 90 days (Article 9);
3. the importing party decides, on the basis of a risk assessment, within 270 days, to approve (with or without conditions), prohibit, request more information or extend the period (Article 10);
4. Article 10(6): lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding potential adverse effects shall not prevent the importing party from taking a decision, as appropriate, in order to avoid or minimise such effects.

6. LMOs for food, feed or processing (Article 11)

Commodity shipments (GM maize or soybean for food or feed, not planting) follow a lighter procedure. A party that approves such an LMO for domestic use, including placing on the market, informs other parties through the Biosafety Clearing-House within 15 days. Importing parties may decide on import under their domestic law, and Article 11(8) repeats the precautionary rule.

7. Risk assessment, management and handling

• Article 15 and Annex III: risk assessments are carried out in a scientifically sound and transparent manner, case by case. The importing party may require the exporter to carry out and pay for the assessment.
• Article 16: risk management measures.
• Article 17: notification of unintentional transboundary movements.
• Article 18: handling, transport, packaging and identification. Food and feed shipments must be identified as “may contain” LMOs; LMOs for release must be clearly identified.
• Article 20: the Biosafety Clearing-House for information exchange.
• Article 23: public awareness and participation, including consultation in decision making.
• Article 26: parties may take into account socio-economic considerations arising from the impact of LMOs on biodiversity, especially their value to indigenous and local communities.
• Article 27: liability and redress. This produced the Nagoya–Kuala Lumpur Supplementary Protocol on Liability and Redress (2010, in force 2018), which requires operators to take response measures for damage to biodiversity caused by LMOs from transboundary movements.

8. Tension with the WTO

The SPS Agreement requires measures to be based on scientific risk assessment, with provisional measures allowed only where evidence is insufficient (Article 5.7). The Protocol’s precautionary approach and socio-economic considerations go further. Its preamble says that trade and environment agreements should be mutually supportive and that the Protocol does not change rights under other agreements, but that this is not meant to subordinate it to them. In EC – Biotech Products (WTO Panel, 2006), brought by the US, Canada and Argentina against the EU’s de facto moratorium on GM approvals, the Panel found the EU in breach of the SPS Agreement and declined to take the Protocol into account because not all disputing parties were bound by it.

9. India’s biosafety regime

• The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells, 1989, made under the Environment (Protection) Act, 1986, predate the Protocol and remain the main law.
• Bodies: Institutional Biosafety Committees, the Review Committee on Genetic Manipulation (under the Department of Biotechnology) for research, and the Genetic Engineering Appraisal Committee (GEAC, under the Environment Ministry) for environmental release; State and District committees for monitoring.
• Section 36(4)(ii) of the Biological Diversity Act requires the Central Government to regulate, manage or control the risks of use and release of LMOs likely to harm biodiversity and human health.
• Bt cotton was approved in 2002. Bt brinjal was approved by the GEAC in 2009, but the Environment Minister imposed a moratorium in 2010 after public consultations. GM mustard (DMH-11) was approved for environmental release in October 2022.

In Gene Campaign v. Union of India, 2024 INSC 545, the challenge to the DMH-11 approval produced a split verdict. Justice B.V. Nagarathna held the GEAC’s decision vitiated; Justice Sanjay Karol upheld it. Both directed the Central Government to frame a national policy on GM crops in consultation with stakeholders, and the matter was placed before the Chief Justice for a larger bench.

How this is examined

Likely long questions. “Discuss the salient features of the Cartagena Protocol on Biosafety.” “Explain the advance informed agreement procedure and the role of the precautionary principle in the Cartagena Protocol.” “Examine India’s regulatory framework for genetically modified organisms in the light of the Cartagena Protocol.”

Likely short notes. Advance informed agreement; Biosafety Clearing-House; living modified organism; LMO-FFPs; Supplementary Protocol on Liability and Redress; GEAC.