GMO AMENDMENT BILL 2005

DEPARTMENT OF AGRICULTURE REPRESENTATIVES DR. SHADRACK R. MOEPHULI:ADGAP (EC: CHAIR) DR. JULIAN B. JAFTHA: SMGRM MS. MICHELLE VOSGES: REGISTRAR MS. NDIVHUO RABULI: LEGAL SERVICES MR. LUFUNO MAKHOSHI: LEGAL SERVICES

STRATEGIES / POLICIES African country – developmental state Convention on Biological Diversity Implementation of GMO Act - 1999 Cartagena Protocol on Biosafety (Articles 8 (g) & 19.3 of CBD) June 2001 - National Biotechnology Strategy Agric – Biotech Strategy published 26/08/05 Biosafety policy – draft published 26/08/05

APPLICABLE LEGISLATION & POLICIES ENVIRONMENT Environmental Conservation Act, 1998 National Environmental Management Act, 1998 National Environmental Management Biodiversity Act, 2004 FOOD SAFETY Foodstuffs, Cosmetics and Disinfectants Act, 1972 ADMINISTRATIVE JUSTICE Promotion of Administrative Justice Act, 2000 Promotion of Access to Information Act, 2000

What have we done to date? Parliamentary Conference – 2003 (DoA, DEAT, DoH etc) Publication in Government Gazette - 8/10/04 Responses from 89 interested & affected parties. Cabinet approval on 11 May 2005 Publication of Explanatory Summary - 26/08/05 Certification by State Law Advisors – 07/10/05

INTRODUCTION TO GMO ACT (Act No. 15 of 1997) Promulgated 1997 and implemented 1999 Objective - Implement measures to ensure RESPONSIBLE activities Including import, production, release & distribution limit adverse impact on environment, human/animal health ensure effective management of waste prevent accidents Measures to evaluate & reduce potential risks Lay down criteria for risk assessment Establishment of Council LMO: Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology

GMO ACT cont GMO’s organism/gene/genetic material – modified - not naturally through mating or natural recombination or both… LMO: any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology --- CPB RSA – GMO = LMO

GMO ACT cndt Act Infrastructure

GMO ACT cntd GMO activities approved to date: General release approvals (commercial use) Maize, Cotton, Soybean Commodity clearance (food and/or feed, not planted) Maize, Soybean, Oilseed Rape Field trial approvals (not all active) Cotton, Maize, Soybean, Sugarcane, Vaccines (HIV), Potatoes, Wheat Contained use (facility/structure bound) Maize, Sweet potato, Potato

Changes required from Protocol Article 17 – Unintentional transboundary movement and emergency measures Notification to BCH, affected & potentially affected parties Measures to minimize significant adverse effects Prescribed information Article 20 – Information sharing & BCH Submission of the following information to BCH: Relevant existing domestic laws, regulations and guidelines Bilateral, regional and multilateral agreements Summaries of risk assessments/environmental reviews Decisions taken on importation or release Monitoring reports on implementation of the protocol etc

Changes required from Protocol Article 27 Liability and Redress Section 17 of principal Act – technical changes Under negotiation – must be in accordance with international rules and procedures in the field of liability and redress for damage resulting from transboundary movement of LMO

Changes required from Protocol Culture & Socio – economic issues (article 26) May consider the following: Impact on biodiversity in areas inhabited or used by indigenous or local communities; Loss of access to genetic resources previously available to indigenous or local communities; Loss of cultural traditions, knowledge, and practices resulting from loss of biodiversity RSA – included in duties & powers of council

PUBLIC AWARENESS & PARTICIPATION Article 23 of Protocol Promote & facilitate awareness, education & participation Provide for access to information Consult with public in decision-making process Public access to BCH RSA approach Public Understanding of Biotechnology – DST PAIA, PAJA, public notifications in newspapers, radio & TV Newspaper adverts Departmental Website: www.nda.agric.za/geneticresources/act15.htm

PUBLIC CONSULTATIONS MP’s – Portfolio Committees of Agriculture and Land Affairs, Environmental Affairs and Tourism, Science & Technology, Health Groups / entities concerned about GMO’s Biowatch, SAFeAge, African Centre for Biosafety, Earthlife Africa, AfricaBio, etc. Seed, grain and animal feed industry Research institutes and scientists Medicines Control Council Processing companies (Tiger Food Brands) Organic Industry Government departments Legal institutes (Legal Resources Centre) Church organizations (Catholic’s Church, Anglican) Individuals (incl. farmers & farmer organisations) Bodies appointed under the GMO Act (Committee, Council, appeal Board) Indicate the extent of participants

SUMMARY OF PUBLIC COMMENTS Need for national policy and redrafting of GMO Act No precautionary approach adopted Publication of proposed amendments to regulations Direction required on different assessments Constitution and related legislation Decision of the Council - majority decision Department of Arts and Culture - be removed as member of the Council Extension permit applications - public consultations & socio-economic considerations in all cases. Extension permits granted for trial release permits without further Council approval Civil representation on Advisory Committee End-user and consumer not “user” Lack of post commercialisation monitoring Not all, only a summary Long term monitoring: a function of South African Biodiversity Institute

GMO AMENDMENT BILL, 2005 Give effect to international agreements - CPB; Amend certain definitions and add new definitions; Amend the composition and remuneration of members of the Committee and Council; Amplify the powers and duties of the Council, the Committee and the functions of registrar Clarify the procedure relating to the application and issuing of permits;

GMO AMENDMENT BILL 2005 Amplify the provisions on risks assessments Amend the liability determinations; Amend the information requirements contemplated in the confidentiality clause; Lay down criteria with regard to offences; Provide for certain procedures during an appeal process

SECTIONS OF THE BILL, 2005 Section 1 – Definitions Amendments to Accident , contained use, general release, New definitions Activity , biosafety, biosafety clearing house, commodity clearance, conditional general release, Convention, environmental impact assessment, extension permit, protocol, release, transboundary movement

SECTIONS OF THE BILL, 2005 cntd Section 3 - Composition of Council 10 members - additions Department of Arts & Culture Department of Water Affairs & Forestry Nominated by departments Knowledge of implications of GMO’s Sector Existing policies & legislation Any other member – ? experts ? motivation

SECTIONS OF THE BILL, 2005 cntd Section 5 - Duties of Council (must..) Type of assessments required Science-based risk assessment Risk management measures Decisions (consensus) – facilities & activities Accidents – notification; emergency measures Section 5 - Powers of Council (may..) Public input Environmental impact assessment Socio-economic considerations Authorise issuance of permit / extension permit Reconsider decisions EIA: elements of the EIA in all risk assessments economic implications of conducting a full EIA.

SECTIONS OF THE BILL, 2005 cntd Section 7 – Functions of the Registrar Subject to instructions from Council Not subject to instruction from Council Register – facilities / trial sites & contact details Interact with Biosafety clearing house Issue extension permits Section 10 – composition of Advisory Committee Public sector representative: expert on human & animal health Public sector representative previously only with expertise in ecological matters, now it also includes human and animal health

SECTIONS OF THE BILL, 2005 cntd Section 17- liability and redress Article 27 of the Protocol Users – appropriate measures to avoid adverse impact on environment, human and animal health Liability – user concerned

SECTIONS OF THE BILL, 2005 cntd Section 18 – Disclosure of information (Protocol – Article 21) General description of GMO Summary of Science-based risk assessment Mechanisms Promotion of Access to Information Act, 2000 – notification Promotion of Administrative Justice Act, 2000 – decisions & reasons for decisions National Biosafety Clearing-House – increase transparency

SECTIONS OF THE BILL, 2005 cntd Section 19 – appeal Time periods Appeal board appointment Decision Type of decisions Confirm, set aside, substitute, amend Other order – minimize significant negative impact on environment or human / animal health New scientific / technical evidence / information – directly applicable

SECTIONS OF THE BILL, 2005 cntd Section 20 – Regulations Time periods- applications / decisions Procedures for drawing up assessments Accidents –notification / information Biosafety Clearing House As prescribed in the amendment

THANK YOU…. QUESTIONS?