The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety has been adopted as a supplementary agreement to the Cartagena Protocol on Biosafety (CPB). The Supplementary Protocol aims to contribute to the conservation and sustainable use of biodiversity by providing international rules and procedures in the field of liability and redress relating to Living Modified Organisms (LMOs).

The Supplementary Protocol requires that response measures are taken in the event of damage resulting from living modified organisms, or where there is sufficient likelihood that damage will result if timely response measures are not taken. The Supplementary Protocol also includes provisions in relation to civil liability.

The issue of elaborating rules on liability and redress for damage resulting from LMOs was under consideration internationally both before and after the adoption of the Protocol on Biosafety. Article 27 of the CPB set the stage for the establishment of a formal process towards completion of the consideration of the issue within a defined timeframe. Article 27 required the Conference of the Parties to the Convention on Biological Diversity serving as the meeting of the Parties to the Biosafety Protocol to adopt, at its first meeting, a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of LMOs.

Accordingly, the first meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety which was held in Kuala Lumpur, from 23 to 27 February 2004, established an Ad Hoc Open-ended Working Group of Legal and Technical Experts on Liability and Redress in the Context of the Cartagena Protocol on Biosafety. To analyze issues, elaborate options, and propose international rules and procedures on the subject. After six years of negotiations, an international agreement, known as the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, was finalized and adopted in Nagoya, Japan, on 15 October 2010 at the fifth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol.

The Supplementary Protocol adopts an administrative approach to addressing response measures in the event of damage or likelihood of damage to the conservation and sustainable use of biological diversity resulting from LMOs that find their origin in transboundary movements. Like its parent treaty, the Cartagena Protocol on Biosafety, the adoption of the Nagoya – Kuala Lumpur Supplementary Protocol is seen as playing a function of preventing damage on the one hand and as a further confidence-building measure on the other, in the development and application of modern biotechnology. It advances the enabling environment for deriving maximum benefit from the potential of LMOs by providing rules for redress or response measures in the event something goes wrong and biodiversity suffers or is likely to suffer damage.

Article 18(1) of the Supplementary protocol sets out the procedure for entry into force.  Art 18(1) reads as follows: “This Supplementary Protocol shall enter into force on the ninetieth day after the date of deposit of the fortieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Protocol”.

The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety therefore entered into force on the 5th of March 2018. There are 51 Signatories and 41 Parties to the Supplementary Protocol. This far fifteen (15) African Countries namely Uganda, Tunisia, Togo, Senegal, Nigeria, Mozambique, Mauritania, Mali, Madagascar, Liberia, democratic Republic of Congo, Chad, Central Africa Republic, Cape Verde and Burkina Faso are signatories to the Supplementary Protocol.


Significance of the Protocol

For the purposes of the Supplementary Protocol, a party bringing a claim for liability or redress must demonstrate that:

  1. there has been an adverse effect on conservation or sustainable use of biological diversity or risks to human health;
  2. the effect is measurable or observable for the purposes of attribution of impacts; and
  3. the adverse effect is significant.

The key actors who may potentially trigger a claim under the Supplementary Protocol are the Operators who include any person in direct or indirect control of an LMO.  This includes the owner. The Supplementary Protocol defined the term owner the term to include non-state actors, including any group in the chain of custody of LMOs.

A major source of contention was whether the text would cover not just LMOs but products thereof such as cloth produced from GM Cotton. One school of though was that Some the language products thereof would expand the Supplementary Protocol beyond the scope of the Cartagena Protocol. The language was ultimately removed from the text, but the Parties agreed that States could apply the Supplementary Protocol to damage caused by processed materials from LMOs as long as a causal link is established. Applying domestic law on causation, a claimant must demonstrate a causal link between the claimed damage and the introduction of an LMO across a boundary.

Where there is a damage claim ripe for adjudication, claimants may be entitled to response measures, including measures to prevent, minimize, contain, mitigate, or otherwise avoid damage as well as actions to restore biological diversity either the condition that existed before the damage occurred or its nearest equivalent. When in situ restoration is impossible, operators are expected to replace biological diversity with species and genetic material that is functionally similar either at the place where the damage occurred or as appropriate, at an alternative location.

The requirement in Article 5 for States to design a domestic legal framework to provide response measures to address transboundary environmental damage by LMOs is the primary new contribution of the Supplementary Protocol. To address concerns that the competent authority could exercise unjust ultra vires powers over private operators, the negotiating Parties agreed that operators must have access to administrative or judicial review of response measures under domestic law.

While some stakeholders in the negotiating process argued for specific international regulations to be negotiated within the Supplementary Protocol, the document as adopted clarifies that there are no internationally agreed upon substantive rules or regulations on the transboundary transfer of LMOs. Rather, Parties will defer to the wisdom and capacity of States operating under their domestic law. For example, many States and civil society stakeholder groups argued for financial guarantees, such as mandatory insurance for operators, or a fund. These proposals were in keeping with the international framework for liability for oil pollution found in the International Convention on the Establishment of an International Fund for Oil Pollution Damage. These efforts to seek internationally based financial security for the movement of any LMOs ultimately were defeated because of concerns by industry that these mechanisms would result in higher prices for genetically modified crops and animals. Instead, States were given the option of whether to require financial security through their domestic law.

In nearly a decade of negotiations leading up to the Supplementary Protocol, several developing States, working in conjunction with environmental and human health non-governmental organizations, failed to prevail on a single standard of strict liability for damage caused by transboundary movements of LMOs. These groups hoped that strict liability would be imposed as the international liability standard in light of the strict liability standards provided under a number of treaties involving hazardous activities, including nuclear energy treaties, outer space treaties, marine treaties, and hazardous waste treaties. The regional Lugano Convention on Civil Liability for Damage Resulting from Activities Dangerous to the Environment imposes strict liability, including liability for damage caused by living modified organisms. While there was State and public interest in setting a strict liability standard for transboundary harm caused by LMOs, the issue was dropped in the final negotiations.

The expectations for collective State action to reduce damage from LMOs are minimal. Instead, the Supplementary Protocol chiefly requires States to provide, in their domestic law, for rules and procedures that address damage by providing response measures either from their existing civil liability law or through new law. It was agreed that new civil liability laws to address transboundary LMOs should include as appropriate damage, standards of liability, channeling of liability, and standing concerns.

What the specialized LMO civil liability regimes will look like remains unknown. While draft guidelines on civil liability and redress had been circulated to Protocol members in hopes of providing models for States without any liability regime for LMOs, all references to these draft guidelines were removed from the adopted text.

The Supplementary Protocol provides a wide berth for States to internally negotiate which liability and redress portions of the Supplementary Protocol will be translated into domestic law. Article 6 provides States with the blanket exception that Parties may provide, in their domestic law, for any other exemptions or mitigations as they may deem fit. This opens up the possibility that non-State Parties engaged in trade in LMOs could put pressure on Parties to make exemptions in their domestic law regarding, for example, specific LMOs subject to the Supplementary Protocol. This section may have been politically necessary because the Supplementary Protocol does not allow for any treaty reservations.

Like the Cartagena Protocol, the Secretariat for the Convention on Biological Diversity in Montreal, Canada will administer the Supplementary Protocol. The Supplementary Protocol will be open for signature at the UN Headquarters from March 7, 2011, to March 6, 2012, and will go into effect after the fortieth ratification.


Conclusion: Challenges Ahead for the Supplementary Protocol

As with the Cartagena Protocol, many of the same key biotech-promoting States who did not sign the Protocol will not be signatories to the Supplementary Protocol.

Biologically diverse States, without large biotech operations and current signatories to the Cartagena Protocol, will likely sign the Supplementary Protocol. This augurs well for creating a fledgling set of universal legal standards for liability and redress for actors involved in the creation, distribution, and the transfer of LMOs. If the 160 Parties to the Cartagena Protocol ratify the Supplementary Protocol, they may create adequate political and legal pressure to require non-Parties to demonstrate that they are prepared to hold their operators accountable for damage caused by LMOs. Ratification by a majority of States would send a clear message that it is internationally unacceptable for any State to cause significant adverse environmental effects by trading in LMOs without proper risk management and assessment.

For the time being, however, the failure to attract ratifications from major biotech producing States raises questions about the legitimacy of the Supplementary Protocol as a tool for ensuring appropriate liability and redress for ecological damage and impacts on human health. As noted in the Conference of Parties Decision BS-V/11, the private sector has undertaken some initiatives to ensure recourse in the event of environmental damage caused by LMOs. Some argue that it was the leadership from the private biotech sector, by agreeing to subject its industry to civil liability to ensure a generally liberalized market in LMOs, that made it possible for States to accept the current draft of the Supplementary Protocol. In 2010, BASF, Bayer CropScience, Dow AgroSciences, DuPont, Monsanto, and Syngenta signed The Compact: A Contractual Mechanism for Response in the Event of Damage to Biological Diversity Caused by the Release of a Living Modified Organism. As members to the Compact, these companies agreed to binding arbitration under the auspices of the Permanent Court of Arbitration if a company has released an LMO that is alleged to have caused damage to biological diversity. As corporate leaders, these companies indicated that they expect Compact members to be properly insured to absorb potential financial losses.

Interestingly enough, the Compact, in contrast to the Supplementary Protocol, provided for specifically elaborated legal standards and an industry contract to limit the parties liability. Similarly, where the Supplementary Protocol requires a response for damage arising from both intentional and unintentional transboundary movements, the Compact members limited member liability for transboundary movements of LMOs to misuses. Likewise, where the Supplementary Protocol provides an open-ended definition for significant adverse effects, the Compact specifically limited compensable environmental damage. Notably, the Compact, unlike the Supplementary Protocol, does not explicitly address adverse effects on human health.

Time will tell whether the legal framework for liability and redress for damage caused by LMOs will be governed primarily by public actors concerned with preserving both biodiversity and sovereignty or largely by private multinational actors concerned with preserving open markets. In the meantime, the international community must hope that the Supplementary Protocol is just a precautionary extension of the legal principles of risk management and assessment embodied in the Cartagena Protocol and that future generations will not need to invoke any of the Supplementary Protocol operative measures.