1. GMO amendment Bill and biotech policy W. De Greef, Consultant to AfricaBio

2. The need to update the GMO Act 1997 Need to adapt RSA legislation to Cartagena Protocol Opportunity to: –reflect on working of the GMO Act –update structures and procedures –adapt to technology evolution Not much needed to be changed!

3. The purpose of biotech regulation GMO biosafety regulation is put in place to ensure that activities with GMOs are conducted safely It is neither a tool for promoting nor for blocking applications of GM technology

4. South Africa and biotech South Africa was one of the first developing nations to assess, adapt and adopt GM crops for both commercial and subsistence farming systems. The research system of South Africa has been a leader in applying GM technology on crops and traits of relevance to third world agriculture. The regulatory system has ensured that this activity has happened without any accidents

5. The consequences RSA is a leader in adapting biotech to serve its agricultural economy It also rapidly becomes a leader in designing entirely new GM crop solutions to African farming problems RSA has most of the research capacity, and all of the farmer experience with GM crops in Africa  The regulatory environment in RSA will influence access to biotechnology for the entire continent

6. The international context The Cartagena Protocol:

7. CP and CBD Art. 16 and 19 of the CBD put the CP in context: –recognise the benefits that can be obtained from safe use of biotechnology –While setting out the need to ensure that technology transfer be properly regulated for safety

8. Relevant CBD articles

11. Comments on the Bill Executive council: –Composition, –Activities –Responsibilities –Consequences for RSA agricultural R&D Liability

12. Composition Executive Council Ensures multidisciplinary approach to the approval process Inclusive in terms of participating government departments and agencies Set up to provide a one-door decision making process for the safe use and development of gene technology;

13. The coordination role of EC Implies that decision procedures through the process set out in Bill (and 1997 Act) are the sole entry point for GM decisions Concern: the coordination of decision making under GMO Act and NEMA Act and Biodiversity Act. –Possibility of parallel decision making –Need for clear agreement on role of the different Acts The consequences of parallel regulation: –Confusion for actors in R&D and in farming –Possibility of divergent decisions  loss of credibility

14. Substitution of Section 5 of 1997 Act (section 4 of the Bill) Most of the new text intends to translate obligations vs. The CP into national law. Concerns: –Provisions of section 4g-4j of the Bill –Text of section 4m Impact on: –Working of farming sector with approved GM seed and commodity crops –The future working of South African researchers, particularly in international cooperation

15. 4g – 4j and farming High probability of transboundary movement of seed and commodity grain produced or sold in RSA  becomes de facto illegal Reason is NOT that these products may be dangerous, but the large gap in regulatory readiness between RSA and its neighbours Precedents:Argentina   Brazil China   several neighbours RSA takes on a lot of liability there without having the tools for pre-emptive action to avoid the issue

16. 4m and transboundary movements Section 4(m): where the Council has been informed by the registrar that there is a reasonable suspicion that an activity is conducted contrary to this Act or to a condition contained in a permit issued under this Act, determine— (i) a place or facility whereto a genetically modified organism used in such a activity or any material or substance used, affected or potentially affected by such activity must be removed; and (ii) appropriate measures for the disposal or repatriation of any genetically modified organism used in such activity or any material or substance used, affected or potentially affected by such activity. Does this work both ways? If so, does RSA take on responsibility for policing all its borders for exports?

17. Section 4 and research cooperation Does not address needs for international research cooperation –This reflects the silence of the Cartagena Protocol on the same issue –Uses single procedure for experimental and commercial materials Consequence: –Rapid decline in international movements of experimental GM materials –Decline in international cooperation and technology transfer –No resources allocated to research community to comply with the very stringent demands of regulators  In contradiction with CBD and CP objectives on technology transfer

18. Section 17 (Act): Liability (section 11 of the Bill) Pre-empts outcome of CP negotiations on Liability and Redress Commits RSA to the outcome before knowing the shape of the agreement Is this really necessary? Consequences: –Most R&D for developing world happens in public research –Has South Africa considered the impact of ALL possible outcomes of the L&R debate on its national research policy?

19. The impact of the Cartagena Protocol Assessing the consequences of making the text of the CP part of the GMO Act

20. Assessment time CP only deals directly with transboundary movements, but: De Facto standard for national regulations Need to assess its assumptions and consequences –Impact on technology transfer –Impact on cost and effectiveness of public research Need to assess the impact on RSA’s position as: –A leading agricultural nation of the South –A leading technology developer and adapter in agriculture Need to foresee financial and operational tools to exercise leadership in Africa and developing world