1. GMO AMENDMENT BILL 2005

2. 2 INTRODUCTION TO GMO ACT (Act No. 15 of 1997)  SAGENE: Advisory role Responsible for evaluation of risk assessment data Amendment of the Regulations of Agricultural Pest Act  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 Executive Council

3. 3 GMO ACT cont  Act Infrastructure

4. 4 GMO ACT cont  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

5. 5 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

6. 6 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 TRADE POLICIES ADMINISTRATIVE JUSTICE  Promotion of Administrative Justice Act, 2000  Promotion of Access to Information Act, 2000

7. 7 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  Parliamentary process

8. 8 PUBLIC CONSULTATIONS  MP’s – Portfolio Committees of Agriculture and Land Affairs, Environmental Affairs and Tourism, Science & Technology, HealthAgriculture 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.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)

9. 9 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

10. 10 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

11. 11 Changes required from Protocol  Article 27 Liability and Redress Section 17 of principal Act – technical changes (applicable to environment human and animal health  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

12. 12 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

13. 13 Changes required from Protocol  Article 23 Public Awareness & Participation 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 www.nda.agric.za/geneticresources/act15.htm

14. 14 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;

15. 15 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

16. 16 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

17. 17 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

18. 18 SECTIONS OF THE BILL, 2005 cntd  Section 5 - Duties of Council (must..) Type of assessments requiredType of assessments required –Science-based risk assessment –Risk management measures Decisions (consensus) – facilities & activitiesDecisions (consensus) – facilities & activities Accidents – notification; emergency measuresAccidents – notification; emergency measures  Section 5 - Powers of Council (may..) Public inputPublic input Environmental impact assessmentEnvironmental impact assessment Socio-economic considerationsSocio-economic considerations Authorise issuance of permit / extension permitAuthorise issuance of permit / extension permit Reconsider decisionsReconsider decisions

19. 19 SECTIONS OF THE BILL, 2005 cntd  Section 7 – Functions of the Registrar Mainly subject to instructions from Council Not subject to instruction from Council –Register – facilities / trial sites & contact details –Interaction with Biosafety clearing house –Issue extension permits  Section 10 – composition of Advisory Committee Public sector representative: expert on human & animal health (previously only ecological)

20. 20 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

21. 21 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

22. 22 SECTIONS OF THE BILL, 2005 cntd  Section 19 – appeal Time periodsTime periods –Appeal board appointment –Decision Type of decisionsType 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 applicableNew scientific / technical evidence / information – directly applicable

23. 23 SECTIONS OF THE BILL, 2005 cntd  Section 20 – Regulations Time periods- applications / decisionsTime periods- applications / decisions Procedures for drawing up assessmentsProcedures for drawing up assessments Accidents –notification / informationAccidents –notification / information Biosafety Clearing HouseBiosafety Clearing House

24. 24 THANK YOU….