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

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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