There are two major international protocols that address genetically modified organisms, the Cartagena Protocol of 2000 and the Nagoya-Kuala Lumpur Supplementary Protocol of 2010. They are attached to the Convention on Biological Diversity of 1993. They apply only to transboundary actions; they do not apply to use or transit of GMOs within countries.
I. Cartagena Protocol
The major international instrument on genetically modified organisms (GMOs) is the Cartagena Protocol on Biosafety (the Protocol) to the Convention on Biological Diversity. The Protocol was adopted on January 29, 2000, and became effective on September 11, 2003. It is designed to protect both biological diversity and human life from any adverse effects of organisms modified by technology. There are at present 166 parties to the Protocol; the United States is not a party.
Biosafety was one of the key issues addressed by the Convention on Biodiversity, which stressed the need to protect human health and the environment from the possibility of negative outcomes of modern biotechnology, while at the same time seeing the potential for good results of innovation in such areas as improving food supplies through agricultural development. In November 1995, the Conference of the Parties to the Convention, at its second meeting, established a working group on biosafety. The goal of the working group was to create a protocol on the topic that would focus on transboundary movement of GMOs, when there may be an adverse impact on “the conservation and sustainable use of biological diversity.” The Protocol was the result of several years of negotiations, including six meetings held between July 1996 and February 1999, concluding in January 2000 at a meeting on the Conference of Parties held in Montreal.
When the Protocol was accepted, the decision was made to set up an “open-ended ad hoc Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP)” that would organize the initial meetings of parties to the Protocol.
A. Purpose and Definitions
The Protocol “provides an international regulatory framework to reconcile the respective needs of trade and environmental protection with respect to a rapidly growing global industry, the biotechnology industry.”
The Protocol itself states that its objective 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.
The Protocol defines “living modified organism” as “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.” “Modern biotechnology” is defined as:
the application of:
a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
b. Fusion of cells beyond the taxonomic family,
that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection . . . .
The Protocol’s scope includes the transboundary movement, transit, handling, and use of GMOs, but it explicitly does not apply to the movement across borders of GMO pharmaceuticals for human use that are covered in other international agreements or addressed by international organizations. Nothing in the document, however, limits a party to it from applying its own decisions on GMO pharmaceuticals. Furthermore, any party can make its own assessment and decisions on import standards for GMOs for contained use within the party’s own borders.
B. Basic Principles for Planned Transport of GMOs
One of the principles on which the Protocol is based is the precautionary principle, a way of determining whether regulation should be used in uncertain circumstances. It was outlined in the 1992 Rio Declaration on Environment and Development, which states that “[w]here 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.” This principle, which favors imposing methods to prevent damage, so long as they are “cost-effective,” has been applied to a number of environmental issues; it is considered a useful way to balance the sometimes conflicting interests of protecting the environment while not overly inhibiting scientific advances and international trade.
The wording of the precautionary principle in some parts of the Protocol was controversial, and States have interpreted its meaning in various ways. While the document authorizes nations to take precautionary decisions even when scientific evidence is unclear as to potential harm from GMOs, there is still disagreement on how to apply this principle. Under the World Trade Organization’s dispute mechanisms, a 2006 panel said that states could not generally rely on nongovernmental organizations’ reports or peer-reviewed journal articles as the basis for applying the precautionary principle in a way that restricted trade.
Under the Protocol, the basic mechanism for regulating transit of GMOs across borders is advance informed agreement, which requires that when there is a plan to move such products across a boundary, parties will be notified in advance. There is a 270-day period in which the party can decide whether to allow the transit and what conditions to impose if permission is granted. The decisions are based on assessment of risk under recognized assessment techniques.
C. Unintended Transboundary Transmission and Information Sharing
The Protocol also contains provisions on accidental movement of GMOs across borders. It specifies that if a party becomes aware that something has occurred that “leads, or may lead, to an unintentional transboundary movement” of a living GMO and if that movement would “have significant adverse effects on the conservation and sustainable use of biological diversity” that may include a risk to human health, then that party has the obligation to notify any affected countries, relevant international organizations, and the Biosafety Clearing House. The Protocol establishes the Biosafety Clearing House to facilitate the exchange of all kinds of information about GMOs and to help parties to the Protocol implement its provisions. The Protocol also states that each participating country should establish a “national focal point” to be responsible for the administrative functions required by the Protocol; information on the designated focal point is available to all parties through the Biosafety Clearing House.
D. Handling and Labeling
The Protocol also specifies that measures must be taken such that GMOs being transported are properly handled, packaged, and safely moved. In addition, documentation must accompany all shipments of GMOs that states that the items may contain GMOs, as well as indicating a contact point for information about the shipment.
E. Illegal Transboundary Transmissions
The Protocol does not include specific penalties for improper transmission of GMOs across borders. Instead it states that parties “shall adopt appropriate domestic measures aimed at preventing and, if appropriate, penalizing transboundary movements” of GMOs when done in a manner that violates Protocol provisions. It also states that parties affected by illegal transmissions may request that the party of origin bear the expense of disposal of such illegally transmitted GMOs, either through repatriation or destruction as appropriate. Furthermore, such cases must be reported to the Biosafety Clearing House.
II. Nagoya-Kuala Lumpur Supplementary Protocol
Following years of negotiations over the question of liability for GMO-produced damages, on October 15, 2010, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (the Supplementary Protocol) was adopted. As of March 2013, only eleven parties to the Protocol had ratified the Supplementary Protocol; it will enter into force ninety days after the fortieth country ratifies or otherwise accepts it.
The Supplementary Protocol provides international rules and procedure on liability and redress for damage to biodiversity resulting from living modified organisms. René Lefeber, one of the co-chairs of the Group of the Friends who facilitated the negotiations of the text of the Supplementary Protocol, spoke about the importance of the adoption of the document and the timing of the move, stating, “[t]he adoption of [a] new supplementary Protocol during the International Year Biodiversity will give new impetus to multilateral environmental negotiations. This agreement will also make important contribution to the on-going work under the Convention on Biological Diversity to protect life on earth.” He has also described the need for the Supplementary Protocol by pointing out that “[s]ince adverse effects may occur in spite of risk-management measures or as a result of the failure to identify the risk of adverse effects, the allocation of the costs of such effects should be anticipated and regulated.”
A. Purpose and Definitions
The Supplementary Protocol states that its objective is to “contribute to the conservation and sustainable use of biological diversity, taking also into account risks to human health, by providing international rules and procedures in the field of liability and redress relating to living modified organisms.” It applies to damage from GMOs that cross borders and defines “damage” as
an adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health that:
(i) Is measurable or otherwise observable taking into account, wherever available, scientifically-established [sic] baselines recognized by a competent authority that takes into account any other human induced variation and natural variation; and
(ii) Is significant . . . .
The Supplementary Protocol further states that whether an adverse effect is significant is determined based on a number of factors, including whether it causes long-term or permanent change, the extent of the qualitative or quantitative change that results, whether it reduces the way in which natural diversity provides goods and services, and the scope of any adverse impact on human health.
B. Basic Principles
The basic principle underlying the Supplementary Protocol is that the polluter must pay for any damage caused. Lefeber notes that this principle has an economic origin, but, he argues, it is not clear whether it applies only to the person or organization in control of the polluting activity or whether liability extends to the state in charge of the area in which the activity occurred. While suggesting that liability of the state could be justified in international law, he notes that it has not been directly supported by existing international instruments. In fact the Supplementary Protocol explicitly provides that it does not affect “the rights and obligations of States under the rules of general international law with respect to the responsibility of States for internationally wrongful acts.”
An additional basic principle is that, for the provisions to apply, a causal link must be established between the damage incurred and the GMO in question.
C. Response Requirements
Under the Supplementary Protocol, parties must require those responsible for damages to immediately inform the authorities, evaluate the damage, and take appropriate response measures. The authorities must also evaluate the damage, as well as identifying the operator that caused the damage and determining needed response measures. If there is a likelihood that damage will occur without timely intervention, the operator of the organization involved is required to take appropriate measures so that damage is avoided. An assessment as to whether damage is likely must be based on available scientific information, including information collected by the Biosafety Clearing House. Authorities may also directly implement response measures when operators of businesses fail to do so. In such cases, the authorities may recover costs from the operators. The decision by a government authority to take action should be relayed to the operator. Response measures must be implemented in accordance with domestic law.
D. Additional Applications of Domestic Law
The Supplementary Protocol allows parties to make specific provisions under their domestic law. It permits exemptions from responsibility when there are acts of war or civil unrest, or acts of God (force majeure), and parties may add other exemptions as they deem appropriate. Domestic law can also be used to establish the time and financial limits of liability for costs incurred in response to damaging GMO events.
Domestic law is also the source for rules and procedures to address the civil liability from damage caused by GMOs. It permits parties to either develop specific civil liability law for GMOs or to apply their existing general laws to such liability.
E. Assessment and Review
Once the Supplementary Protocol has been in force for five years, and at five-year intervals thereafter, the effectiveness of the agreement will be reviewed by the Conference of the Parties. The Conference of the Parties serving as the meeting of the parties for the Cartagena Protocol serves as the Conference of the Parties to the Supplementary Protocol.
Constance A. Johnson
Senior Legal Research Analyst
 The Cartagena Protocol on Biosafety, Convention on Biological Diversity, http://bch.cbd.int/protocol/; Protocol text in English, http://bch.cbd.int/protocol/text/ (both last visited Oct. 24, 2013).
 EXCOP 1 Decision EM-I/3, Adoption of the Cartagena Protocol and Interim Arrangements, http://www.cbd.int/decision/cop/default.shtml?id=7174 (last visited Sept. 30, 2013).
 The Cartagena Protocol on Biosafety, supra note 1.
 Introduction, Cartagena Protocol on Biosafety, supra note 1.
 EXCOP 1 Decision EM-I/3, § II no. 5, supra note 3.
 Cartagena Protocol art. 1.
 Id. art. 3(g).
 Id. art. 3(i).
 Id. arts. 4-6.
 Rio Declaration of the United Nations Conference on Environment and Development, Principle 15 (June 14, 1992), http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm.
 For an example of a discussion of the role of the precautionary principle in balancing these conflicting interests, see John S. Applegate, The Prometheus Principle: Using the Precautionary Principle to Harmonize the Regulation of Genetically Modified Organisms, 9 Indiana J. Global Legal Stud. 207 (2001).
 Ruth Mackenzie, The Cartagena Protocol on Biosafety and the Development of International Environmental Law, The International Politics of Genetically Modified Food: Diplomacy, Trade and Law 213, 217 (2007).
 World Trade Organization, European Communities – Measures Affecting the Approval and Marketing of Biotech Products: Panel Report, Dispute 291 (2006), http://www.wto.org/english/tratop_e/ dispu_e/cases_e/ds291_e.htm, discussed in Marie-Claire Cordonier Segger & Markus Gehring, Trade and Investment Implications of Implementing the Cartagena Protocol, Legal Aspects of Implementing the Cartagena Protocol on Biosafety 471, 482 (2013).
 Cartagena Protocol, arts. 6-8.
 Id. art 10 § 3.
 Mackenzie, supra note 15, at 214; see Cartagena Protocol arts. 15 & 16, for provisions on risk assessment.
 Cartagena Protocol art. 17 § 1.
 Id. art. 20 § 1.
 Id. art. 19.
 Id. art. 18.
 Id. art. 25.
 Press Release, The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (Oct. 16, 2010), http://bch.cbd.int/protocol/nkl_pressrelease.shtml; Supplementary Protocol text, http://bch.cbd.int/protocol/nkl_text.shtml (last visited Sept. 19, 2013); René Lefeber, The Legal Significance of the Nagoya-Kuala Lumpur Supplementary Protocol: The Result of a Paradigm Evolution, Amsterdam Law School Research Paper No. 2012-87 (Sept. 24, 2012), available at http://papers.ssrn.com/sol3/papers.cfm? abstract_id=2151282.
 The Cartagena Protocol on Biosafety, and its Nagoya—Kuala Lumpur Supplementary Protocol on Liability and Redress, Convention on Biodiversity,http://www.cbd.int/undb/media/factsheets/undb-factsheet-biosafety-en.pdf (last visited Oct. 23, 2013); Supplementary Protocol, art. 18.
 Press Release, supra note 25.
 René Lefebar, The Legal Significance of the Nagoya-Kuala Lumpur Supplementary Protocol: The Result of a Paradigm Evolution, Centre for Environmental Law & Sustainability Research Paper No. 2012-02, Amsterdam Law School Research Paper No. 2012-87 (2012), available at http://ssrn.com/abstract=2151282 (click on “Download This Paper”).
 Supplementary Protocol art. 1.
 Id. art. 2 § 2 (b) & art. 3.
 Id. art. 2 § 3.
 Lefebar, supra note 28, at § 2.
 Supplementary Protocol art. 11.
 Id. art. 4.
 Id. art. 5.
 Id. art. 6.
 Id. arts. 6 & 7.
 Id. art. 12.
 Id. arts. 13–14.
Last Updated: 05/22/2014