The advance informed agreement (AIA) procedure for transboundary movement of living modified organisms (LMOs) intended for introduction into the environment, as set forth in the Cartagena Protocol on Biosafety, includes (in Article 7 paragraph 4) an opportunity for exemptions of LMOs ‘identified in a decision of the COPMOP to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversityArticle 13 of the Cartagena Protocol on Biosafety describes a ‘simplified procedure’ by which ‘a Party of import may…specify in advance to the BCH:… (b) Imports of living modified organisms to it to be exempted from the advance informed agreement procedure

Now, with more than twenty years of experience with implementation of the Protocol and introductions of LMOs, Parties may consider establishing a process by which such a decision of the COPMOP on ‘organisms not likely to have adverse effects’ can be taken. In this side event, we will consider two Cry proteins, Cry1Ab and Cry2Ab, expressed by genes from the bacterium Bacillus thuringiensis in LM crops for insect resistance as a case to consider in the development of such a process. By the end of 2025, multiple maize events and breeding stacks, and other crops including cotton, cowpea, eucalyptus, rice, and sugarcane, expressing Cry1Ab have been assessed for environmental safety and approved as safe for cultivation in more than 20 countries.  Maize, cotton, and soybean events and breeding stacks expressing Cry2Ab have also been approved for cultivation in more than 20 countries. These safety assessments have considered similar potential adverse effects on the environment, and on biodiversity, due to the expression of the Cry proteins and possible pathways to harm in different crops and diverse environments. They all reached the same conclusion: that adverse effects on biodiversity are not likely. This has included application of a common approach to non-target organism (NTO) assessment, which is the primary adverse effect on biodiversity considered in the case of crops modified to produce a pesticidal substance.

Closely tied to this discussion is the concept of data transportability for environmental risk assessment, which along with the concept of simplified procedures, has been a point of discussion in the online forum and by the AHTEG for risk assessment and risk management. The concept of data transportability, which relies on identifying specific, hypothesis-driven risks associated with a specific LMO rather than gathering general, extraneous data, is gaining considerable attention in the regulatory community as experience with safety assessments for LM crops has increased.  Article 14 of the Protocol also specifically encourages bilateral, regional, and multilateral agreements among Parties, which may serve as a starting point for more broad agreements among Parties of the Protocol. Finally, Article 20 addresses information sharing, including summaries of risk assessments, among Parties through the BCH. Examples of processes for information sharing and sharing of risk assessments in bilateral, regional and multilateral agreements exist that could possibly be extended to similar processes for the Parties of the Protocol.  We will discuss these points as they relate to the Cry proteins in this side event.

AGENDA