1. GMO AMENDMENT BILL 2005

2. 2 PRESENTERS  Julian JafthaDoA  Ben DurhamDST  Leseho SelloDEAT  Modiegi SelematselaDoH  Ndivhou RabuliDoA  Mbudzeni SibaraAdvisory Committee Chairperson

3. 3 ORDER OF PRESENTATIONS  Some general concerns Precautionary Approach Protection of indigenous seeds Biotechnology in South Africa Scientific safety assessments  GMO Amendment Bill Environmental Impact Assessments Labeling Regulations Liability and Redress Sections of the Amendment Bill

4. 4 PRECAUTIONARY APPROACH?  Principle 15 of Rio Declaration in 1992– In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost effective measures to prevent environmental degradation  Lack of consensus on the status as a principle of law  GMO Act: Implemented through risk assessment and risk management  Protocol: – Annex III

5. 5 PRECAUTIONARY APPROACH cont  Where decision is necessary, measures based on the precautionary approach should be: Proportional to risk Non-discrimination Consistent Based on cost-benefit assessment Subject to review Capable of assigning responsibility for producing scientific evidence

6. 6 Protection of the indigenous seeds  Farm saved seeds Seed vigour Not limited to GMO’s Plant Breeders’ Rights Act International Treaty on Plant Genetic Resources for Food and Agriculture Policy on indigenous crops  Conservation Collection, characterisation and storage of indigenous seeds National Gene Bank Seed diversity fairs

7. 7 BIOTECHNOLOGY IN SOUTH AFRICA DEPARTMENT OF SCIENCE AND TECHNOLOGY

8. 8 SCIENTIFIC SAFETY ASSESSMENTS CHAIRPERSON ADVISORY COMMITTEE

9. 9 ENVIRONMENTAL IMPACT ASSESSMENT DEPARTMENT OF ENVIRONMENTAL AFFAIRS AND TOURISM

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22. 22 LABELING REGULATIONS DEPARTMENT OF HEALTH

23. 23 Foodstuffs, Cosmetics, Disinfectants Act  Any person shall be guilty of an offence if he sells, manufactures, or imports for sale any foodstuffs, which is harmful or injurious to human health  Empowers the Minister to make regulations prescribing the manner in which foodstuffs shall be labelled.

24. 24 GM Food Labelling Regulations  Regulations relating to the labelling of foodstuffs obtained through certain techniques of gene modification were published in 2004  Based on Codex Alimentarius principles for labelling, definitions and concepts

25. 25 Codex Alimentarius Commission  “Food rules”was established in 1962, protect consumer health and facilitate trading practices  Codex Committee on Food Labelling developing guidelines on GM food labelling since 1995

26. 26 GM Food Labelling  Mandatory Requirements A GM food differs significantly in composition, nutritional value, storage, preparation The presence of allergen from crustaceans, eggs, fish, groundnuts, molluscs, soy beans, tree nuts and Triticum species

27. 27 GM Food Labelling  Voluntary claim Genetically improved or enhanced characteristics –Validated and Certified by a body accredited to SANAS –Name of certifying body has to appear next to the claim –Regulations governing the labelling and advertising of foodstuffs published under GN No. R2034 of October 1993

28. 28 GM Food Labelling  Labelling of GM foods is not mandatory Require product differentiation between GM and GM raw materials prior to use in processing Need for a certification system for monitoring and verification Threshold level of tolerance for commingling

29. 29 GM Food Labelling  Australian study 8-18% cost increase Canada 35-41% of the producer prices The Philipines?

30. 30 GM Food Labelling  No provision for non-GM claims  Identity Preservation System Identity of a non-GM and products is preserved by segregating the handling and processing thereof from those of a GMO and its products SABS, Health, and Agriculture developing guidelines to provide for grains, fruit and vegetables, meat and fish and products thereof

31. 31 GM Food Labelling  Current regulations can be regarded as interim measure pending the following Finalization of an Identity Preservation System Progress at the Codex Committee on food labelling

32. 32 LIABILITY AND REDRESS DEPARTMENT OF AGRICULTURE

33. 33 LIABILITY AND REDRESS  Existing liability regime Common law Gaps  Channeling of liability  Type of liability Strict Fault-based

34. 34 GMO AMENDMENT BILL DEPARTMENT OF AGRICULTURE

35. 35 GMO AMENDMENT BILL Insert cartoon

36. 36 GMO AMENDMENT BILL Section 1 – Definitions  Transboundary movement cross border vs across boundaries  Contained use Movement & storage  User Consumer & end-user  Activity Use  Commodity clearance Relation to definition of release

37. 37 GMO AMENDMENT BILL Section 5 – Powers and duties of the Council  Discretionary power Different activities Environmental release –Public input, EIA, socio-economic impact –Regulations  Science based risk assessment Convention on Biodiversity Cartagena Protocol Separate assessment for socio-economic impact

38. 38 GMO AMENDMENT BILL Section 5 – Powers and duties of the Council  Public input Conflict in time periods – GMO Act & PAIA Access to information - What information is confidential? –Provisions of the Protocol –PAIA as basis –Section 18 Transparency –Feedback on decisions made –National Biosafety Clearing House

39. 39 GMO AMENDMENT BILL Section 7 – Meetings of the Council  Consensus decision Members present vs all members Different sectors / policies / legislation Effective decision-making –Prior consideration –Meeting

40. 40 GMO AMENDMENT BILL Section 9 – Functions of the Registrar  Too much power?  Most functions subject to Council instruction  Without instruction Maintain register – facilities & trial releases Routine inspections Suspects possible contraventions –Cessation / dispose / repatriate Submit application & documents to Council Communicate Council decisions to Biosafety Clearing House Extension permits –Subject to terms & conditions of Council –Already previously approved –Reporting to Council

41. 41 GMO AMENDMENT BILL Section 10 – Composition of the Advisory Committee  Why specific requirement for ecologist? Reason – Protocol –Protection of the environment –Including human (and animal) health 1 st level assessment - assess environmental, human and animal health concerns  Other experts less important? Co-opting knowledgeable persons Appointment of sub-committees

42. 42 GMO AMENDMENT BILL Section 15 – Appointment of inspectors  Self regulation? No independent review of assessments –Advisory Committee function No monitoring of compliance with permit conditions –Routine inspections – section 16

43. 43 GMO AMENDMENT BILL Section 19 – Appeal  Time periods? Convening of Board Taking decision Communicating further action by Minister  The type of information to be considered in an appeal Limited to “scientifically proven information”