One of the main mechanisms of the CPB is the AIA procedure, which allows Parties that have not yet adopted a domestic regulatory framework for biosafety, to make informed decisions about the import of LMOs for introduction into the environment of that Party. Article 10 stipulates that “Decisions taken by the Party of import shall be in accordance with Article 15.” Article 15 stipulates that risk assessments under the CPB shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Article 16 addresses management of risks that have been identified in the risk assessment.
Earlier the MOP established an open on line forum and an ‘ad hoc technical expert group’ (AHTEG) to develop guidance for the practical implementation of the general methodology of risk assessment as laid down in Annex III of the CPB. The draft guidance was discussed in MOP6.
From the annotated agenda for MOP7 (ITEM 12):
MOP6 commended the progress made, underlining that the Guidance is not prescriptive and does not impose any obligations on Parties; and that the Guidance will be tested nationally and regionally.
MOP6 extended the open-ended on-line forum, and established a new AHTEG to discuss:
- The testing of the Guidance;
- Alignment of the Guidance with a training manual titled “Risk Assessment of LMOs”; and
- A recommendation on development of further guidance on specific topics of risk assessment.
MOP6 requested the Executive Secretary to:
- Analyse feedback on testing the Guidance for practicality, usefulness, utility, consistency with the Protocol; and taking into account past and present experiences with LMOs;
- Provide a report on possible improvements to the Guidance;
- Create sections in the BCH on LMOs 1) that may have or 2) are not likely to have adverse effects
For MOP7 the Parties will have before them the following documents:
- a note by the CBD Sec on risk assessment and risk management (UNEP/CBD/BS/COP-MOP/7/10)
- the report of the AHTEG (UNEP/CBD/BS/COP-MOP/7/10/Add.1).
- summary of the results of the testing of the Guidance (UNEP/CBD/COP-MOP/7/INF/3);
- a synthesis of the survey on the Strategic Plan for the Protocol (UNEP/CBD/COP-MOP/7/INF/4);
- a report of the Online Forum (UNEP/CBD/COP-MOP/7/INF/5);
- the alignment of the Training Manual and the Roadmap (UNEP/CBD/COP‑MOP/7/INF/6).
- The summary of the testing results shows a very mixed feedback, ranging from countries and organisations expressing satisfaction with the Guidance to countries and organisations, including PRRI, expressing concerns with regard to practicality, usefulness, utility, consistency with the Protocol, and taking into account experiences with LMOs. To give due recognition to the various comments made, the MOP would advised to establish a robust and transparent process for the analysis and incorporation of the comments.
- Many Parties have not been able, or do not have the capacities, to conduct a thorough testing.
- Given the complexity of developing useful guidance, the question arises whether the way in which the on-line conferences and AHTEG are conducted are the most appropriate approach for this task;
Two suggested changes:
- The on-line conferences and AHTEG should focus on identifying and capturing in clear language areas where there is internationally sufficient consensus among scientists, rather than trying to actually develop new guidance in new areas,
- The way in which the ‘Party Driven Process” of the AHTEG on risk assessment is currently conducted, does not make the best use of the available expertise.
- Possible improvements to the Guidance:
The Guidance needs be improved in terms of practicality, usefulness, utility, consistency and experience base, through, inter alia:
- The Guidance, and especially the Roadmap, should be clearer and shorte
- The Guidance should make clear that the environmental risk assessment (ERA) of Annex III is conducted in a systematic, stepwise fashion, that can be summarised as:
- Identify phenotypic, genotypic, intended, and unintended changes in the LMO.
- Assess whether these changes are significant, biologically relevant, and may have adverse effect.
- Evaluate whether identified potential adverse effects are acceptable or manageable
- The Guidance should better explain that
- in plant breeding there are typically many changes in the resulting plants, and that not every observed change implies risk.
- there is no ‘one-size-fits-all’ recipe for ERA, because the points to consider and the level of detail depend on the recipient organism (plant, micro-organism, animal), the inserted sequences and traits, the type of intended use (e.g. confined field trials, unconfined releases) and the likely receiving environment.
- Not all the ‘points to consider’, data and tests are necessary in all cases.
- Over the last decades, a wealth of experience with LMOs has been accumulated and the Guidance should clarify how to get access to that experience and how to best make use of it.
- Further Guidance: given the mixed feedback on the testing of the guidance, it is recommended that the focus should first be on improving the current guidance before embarking on guidance for new topics.
PRRI will post a paper on the PRRI website to address these points in more detail