South African Biosafety Regulatory Framework Julian Jaftha Director: Genetic Resources Management 2 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 3 GMO Amendment ACT (Act No. 23 of 2006) Alignment with Cartagena Protocol on Biosafety Alignment with other legislation such as NEMA Amendment of: the scope Amend and add definitions Amend composition of EC (incl. DWAF, DAC) Facilitate the administrative procedures of the Act Amplify the duties of the EC, AC & Registrar Clarify application process Risk assessment in line with new legislation Procedures during appeal process 4 GMO Amendment ACT (Act No. 23 of 2006) Consultation process Department of Agriculture Parliamentary Conference 2003 Publication in Government Gazette Approved by Cabinet approval in May 2005 Parliamentary process: Portfolio committee on Agriculture and Land Affairs Portfolio committee on Agriculture and Land Affairs Public hearings (January 2006) Consultations with NCOP Approved by President in April 2007 5 GMO ACT Act Infrastructure 6 REGISTRAR Administration of Act Secretariat - essential link between other biosafety structures Duties/functions - instructions of Executive Council Process applications Issue / amend / withdraw permits Ensure compliance Appoint inspectors 7 ADVISORY COMMITTEE National advisory body on all GMO matters Scientists in applicable fields Sub-committee - more expertise & building capacity Primary safety assessment of all applications Recommendation report based on safety assessment (advise EC) 8 EXECUTIVE COUNCIL DoADEATDoH thedtiDoLDST DWAFDAC Chairperson of Advisory Committee Decision (consensus) based on - recommendation report application & public input & previous trial reports sector input (e.g. socio, economic, etc) 9 INSPECTORS Appointed by Registrar - Department of Agriculture assisted by other departments Routine inspections Aim: Ensure adherence to permit conditions possible contravention - investigation - warrant Measure effectiveness of risk management measures Detection of adverse impact Inspection reports 10 Public Participation Promotion of Access to Information Act Promotion of Administrative Justice Act Public understanding of Biotechnology Programme (DST) Newspaper Notifications Departmental website Agricultural shows, exhibitions 11 Public Participation Confidential Business information (gene sequences & construct, methodologies, processes) Non-confidential Business Information: Name & Address of applicant A general description of the GMO The risk assessment Risk management measures Non-CBI copies of applications Facilitation by DoA 12 APPEAL BOARD Any person aggrieved by decision/action by Council, registrar or inspector - appeal to Minister Minister appoint appeal board with required expertise Decisions of appeal board - confirm/ set aside/ amend decision or action refer back to Council (via registrar) any other order Decision to Minister - informs appellant 13 PERMITS Different for each activity: import, export, contained use, trial release, general release Information: Contact details Identity & trait of GMO Quantity & varieties Time period Containment conditions prior to planting, how to plant, what to do during harvest, after harvest, security 14 Approved Activities under the GMO ACT General release approvals (commercial use) Maize (incl. stacked) Cotton (incl. stacked) Soybean Commodity clearance (food and/or feed, not planted) Maize, Soybean, Oilseed Rape 15 Approved Activities under the GMO ACT Field trial approvals (not all active) Crops Cotton Maize (incl. drought tolerance) Soybean Sugarcane (antimicrobials, increased CH content) Potato (insect resistance) Vaccines Tuberculosis HIV 16 Approved Activities under the GMO ACT Contained use (facility/structure bound) GM bacteria producing amino acids Insect resistant sweet potato Cassava (improved starch content) Registered Facilities across the country 17 Non-Approvals under the GMO ACT Field trials with improved a/a GM Sorghum Field trials with improved starch content GM Cassava Contained use with GM flowers Trial release of GM mosquitocide Trial release of recombinant measles vaccine General release of genetically modified yeasts strain 18 Supporting elements to the GMO Act Guideline documents for applications Guidelines for compiling a public notice Guideline document for use by the Advisory Committee Standard Operating Procedures [Reg 2(2)] 19 Supporting elements to the GMO Act Policy on GMO consignments in transit Policy on extension of permits Terms of reference for subcommittees 20 Thank you 21 22 APPLICABLE LEGISLATION & POLICIES AGRICULTURE Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 Plant Breeders right Act, 1976 Plant Improvement Act, 1976 SPS legislation ENVIRONMENT Environmental Conservation Act, 1998 National Environmental Management Act, 1998 National Environmental Management Biodiversity Act, 2004 23 APPLICABLE LEGISLATION & POLICIES FOOD SAFETY Foodstuffs, Cosmetics and Disinfectants Act, 1972 ADMINISTRATIVE JUSTICE Promotion of Administrative Justice Act, 2000 Promotion of Access to Information Act, 2000