CPB – MOP7 – Risk Assessment

PRRI Statement on Risk Assessment

Thank you, Madam Chair,

I speak on behalf of the Public Research and Regulation Initiative. PRRI is a worldwide organisation of public researchers involved in biotechnology for the common good.

PRRI congratulates you as Chair, and thanks the Government and people of Korea for the warm hospitality.

Madam Chair, one of the important outcomes of the negotiations on the Protocol is that it reflects international agreement on the general principles and methodology for risk assessment, building on many years of experience.

PRRI welcomed the decision of the MOP to develop guidance, because good guidance is helpful for new risk assessors and can contribute to international harmonisation.

PRRI therefore actively contributed to the AHTEG and the online discussions, to make our members’ vast collective experience in risk assessment available to this process.

As PRRI already indicated in MOP6, we believe that the current draft guidance, is a good start, but still needs extensive revision, streamlining and update.  We were therefore encouraged that MOP6 decided that the guidance should first be tested.

The results of the testing range from satisfaction to concerns about usefulness, consistency with the Protocol, and taking into account the most up to date knowledge and experience. We also note that most Parties have not been able to finalise testing.

Madame Chair, in the discussions we have heard hints to adopt the guidance.  PRRI believes that this would be unwise, bearing in mind that the over 80 pages with comments have not yet been analysed and incorporated, and bearing in mind that poor guidance is counterproductive to new risk assessors and to international harmonisation.

PRRI therefore recommends that, before embarking on any new guidance, the testing of the current guidance be finalised, analysed and used to improve and streamline the guidance, in a transparent process.

PRRI further recommends that the modus operandi of the AHTEG and online conferences be strengthened to secure that the discussions stay within the relevant provisions of the Protocol and to secure that views of experts that do not come from Parties are fully taken into account.

PRRI continues to be ready to mobilise the large collective expertise of its public research members to help improve the guidance.

Thank you Madam Chair,