ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology Home | Related ICTSD Outputs | News | Resources | Links | WTO Dispute

Biotechnology: Addressing Key Trade and Sustainability Issues

Index

B.3 Cartagena Protocol on Biosafety

Q17 How does the role of precaution differ under the Cartagena Biosafety Protocol and the SPS Agreement?

Elements of the precautionary approach find reflection in a number of the provisions of the Protocol, including the decision-making processes of the AIA mechanism and the procedure for living modified organism intended for direct use as food or feed, or for processing. The precautionary approach is also reflected in various provisions of the SPS Agreement, most importantly allowing countries to adopt provisional sanitary and phytosanitary measures in cases where scientific information is insufficient. Again, the question is nevertheless how a measure based on the provisions in the Protocol would fare under the SPS Agreement requirements.

The approach of both agreements appears to be quite similar. Article 10.6 and 11.8 of the Protocol state that

Measures allowed by Article 5.7 of the SPS Agreement constitute a qualified exemption to the risk assessment requirements. As such, they must comply with four cumulative requirements: (1) relevant scientific information must be insufficient; (2) the measure must be adopted on the basis of available pertinent information; (3) the country must obtain additional information necessary for a more objective assessment of risk; and (4) the measure must reviewed within a reasonable period of time.

Differences may arise, though, in some critical details. For example, both the Protocol and the SPS Agreement include “insufficient scientific evidence” as an element of their precautionary language. However, while in the Protocol it is the uncertainty caused by insufficient evidence that prompts the precautionary approach, the WTO Appellate Body has affirmed that Article 5.7 is not triggered by scientific uncertainty (WTO, 2003). Would a precautionary decision taken using the AIA procedure – where the amount of scientific studies on a particular GMO was considerable but did not prove conclusive – qualify under Article 5.7? It is likely. “Insufficient scientific evidence” under Article 5.7 has never been read to refer to the mere quantity of relevant scientific information. Since uncertainty generally will not allow, in qualitative terms, the performance of an adequate risk assessment, uncertainty by itself would not trigger Article 5.7 but would play a crucial role in determining whether scientific evidence was “insufficient” within the meaning of Article 5.7 (CIEL et al., 2004).

Other differences that could result in conflict include the additional requirements in Article 5.7 of the SPS Agreement for Members to adopt precautionary measures. For instance, measures taken under Article 5.7 may only be provisional – a limitation that is not in the Protocol. However, under Article 12 of the Protocol, all importing decisions are in fact subject to review. An exporting party may request the importing party to review its decision if it considers that additional relevant scientific or technical information has become available. The importing party is obliged to respond in writing to such a request within ninety days and set out the reasons for its decision. Moreover, it should be noted that the Appellate Body has established certain flexibility in regard to the Article 5.7 review, having stated that the meaning of a “reasonable period of time” must be established on a case-by-case basis, because it depends on the specific circumstances of each case, including the difficulty of obtaining the additional information necessary for the review and the particular characteristics of the provisional SPS measure (WTO, 1999). Another element of Article 5.7, though, the requirement that Members seek to obtain additional information in relation to the precautionary measures, is unparalleled in the Protocol.

Nevertheless, it is generally considered that the two approaches to precaution, while not identical, are complementary (Cosbey and Brugiel, 2000). In this regard, it has been argued that, while the Protocol is not one of the international standards recognised by the SPS Agreement, it may provide significant guidance in its application to measures relating to GMOs – particular those based on the precautionary approach. In the Report of the EC-Biotech case, the Panel found that the WTO dispute settlement process was not obliged to look at agreements that had not been ratified by all parties to the dispute (WTO, 2006). However, it did state that a Panel could consider other relevant rules of international law when interpreting the terms of WTO agreements if such rules were deemed to be informative.