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GMO AMENDMENT BILL 2005

GMO AMENDMENT BILL 2005. 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

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GMO AMENDMENT BILL 2005

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  1. GMO AMENDMENT BILL 2005

  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. GMO ACT cont • Act Infrastructure

  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. 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. 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. 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. 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)

  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. 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. 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. 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. 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

  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. 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. 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. 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. 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

  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. 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. 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. 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

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

  24. THANK YOU….

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