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DEPARTMENT OF AGRICULTURE REPRESENTATIVESDEPARTMENT 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
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STRATEGIES / POLICIESSTRATEGIES / 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
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APPLICABLE LEGISLATION & POLICIESAPPLICABLE 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
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What have we done to date? What have we done to date?
Parliamentary Conference – 2003 (DoA, DEAT, DoH Parliamentary Conference – 2003 (DoA, DEAT, DoH etc)etc)
Publication in Government Gazette - 8/10/04Publication in Government Gazette - 8/10/04
Responses from 89 interested & affected parties. Responses from 89 interested & affected parties.
Cabinet approval on 11 May 2005Cabinet approval on 11 May 2005
Publication of Explanatory Summary - 26/08/05Publication of Explanatory Summary - 26/08/05
Certification by State Law Advisors – 07/10/05Certification by State Law Advisors – 07/10/05
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INTRODUCTION TO GMO ACT (Act No. 15 of 1997)INTRODUCTION TO GMO ACT (Act No. 15 of 1997)
Promulgated 1997 and implemented 1999Promulgated 1997 and implemented 1999 Objective - Implement measures toObjective - Implement measures to
– ensure RESPONSIBLE activitiesensure RESPONSIBLE activities
– Including Including importimport, production, release & , production, release & distribution distribution
– limit adverse impact on environment, limit adverse impact on environment, human/animal healthhuman/animal health
– ensure effective management of wasteensure effective management of waste
– prevent accidentsprevent accidents
– Measures to evaluate & reduce potential risksMeasures to evaluate & reduce potential risks
– Lay down criteria for risk assessmentLay down criteria for risk assessment
– Establishment of CouncilEstablishment of Council
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GMO ACT contGMO ACT cont
GMO’s GMO’s
organism/gene/genetic material – modified - not organism/gene/genetic material – modified - not naturally through mating or natural recombination or naturally through mating or natural recombination or both…both…
LMO: any living organism that possesses a novel LMO: any living organism that possesses a novel combination of genetic material obtained through combination of genetic material obtained through the use of modern biotechnology --- CPBthe use of modern biotechnology --- CPB
RSA – GMO = LMORSA – GMO = LMO
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GMO ACT cndtGMO ACT cndt
Act Infrastructure Act Infrastructure
RReeggiissttrraarr -- AAddmmiinniissttrraattiioonn
AAddvviissoorryy CCoommmmiitttteeee ((AACC)) -- NNaattiioonnaall aaddvviissoorryy bbooddyy
EExxeeccuuttiivvee CCoouunncciill ((EECC)) -- DDeecciissiioonn mmaakkiinngg bbooddyy
IInnssppeeccttoorrss -- MMoonniittoorriinngg
AAppppeeaall BBooaarrdd -- RReevviieeww ddeecciissiioonnss
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GMO ACT cntdGMO ACT cntd
GMO activities approved to date: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
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Changes required from ProtocolChanges 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
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Changes required from Protocol 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
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Changes required from ProtocolChanges 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
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PUBLIC AWARENESS & PARTICIPATIONPUBLIC 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
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PUBLIC CONSULTATIONS PUBLIC CONSULTATIONS
MP’s – Portfolio Committees of MP’s – Portfolio Committees of • Agriculture and Land Affairs, Environmental Affairs Agriculture and Land Affairs, Environmental Affairs
and Tourism, Science & Technology, Healthand Tourism, Science & Technology, Health Groups / entities concerned about GMO’sGroups / entities concerned about GMO’s
• Biowatch, SAFeAge, African Centre for Biosafety, Biowatch, SAFeAge, African Centre for Biosafety, Earthlife Africa, AfricaBio, etc.Earthlife Africa, AfricaBio, etc.
Seed, grain and animal feed industrySeed, grain and animal feed industry Research institutes and scientistsResearch institutes and scientists Medicines Control CouncilMedicines Control Council Processing companies (Tiger Food Brands)Processing companies (Tiger Food Brands) Organic IndustryOrganic Industry Government departmentsGovernment departments Legal institutes (Legal Resources Centre)Legal institutes (Legal Resources Centre) Church organizations (Catholic’s Church, Anglican)Church organizations (Catholic’s Church, Anglican) Individuals (incl. farmers & farmer organisations)Individuals (incl. farmers & farmer organisations) Bodies appointed under the GMO Act (Committee, Bodies appointed under the GMO Act (Committee,
Council, appeal Board)Council, appeal Board)
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SUMMARY OF PUBLIC COMMENTSSUMMARY OF PUBLIC COMMENTS
Need for national policy and redrafting of GMO ActNeed for national policy and redrafting of GMO Act No precautionary approach adopted No precautionary approach adopted Publication of proposed amendments to regulationsPublication of proposed amendments to regulations Direction required on different assessmentsDirection required on different assessments Constitution and related legislationConstitution and related legislation Decision of the Council - majority decision Decision of the Council - majority decision Department of Arts and Culture - be removed as Department of Arts and Culture - be removed as
member of the Councilmember of the Council Extension permit applications - public consultations Extension permit applications - public consultations
& socio-economic considerations in all cases.& socio-economic considerations in all cases. Extension permits granted for trial release permits Extension permits granted for trial release permits
without further Council approvalwithout further Council approval Civil representation on Advisory CommitteeCivil representation on Advisory Committee End-user and consumer not “user” End-user and consumer not “user” Lack of post commercialisation monitoringLack of post commercialisation monitoring
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GMO AMENDMENT BILL, 2005GMO AMENDMENT BILL, 2005
Give effect to international agreements - CPB;Give effect to international agreements - CPB;
Amend certain definitions and add new definitions;Amend certain definitions and add new definitions;
Amend the composition and remuneration of members Amend the composition and remuneration of members of the Committee and Council; of the Committee and Council;
Amplify the powers and duties of the Council, the Amplify the powers and duties of the Council, the Committee and the functions of registrarCommittee and the functions of registrar
Clarify the procedure relating to the application and Clarify the procedure relating to the application and issuing of permits; issuing of permits;
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GMO AMENDMENT BILL 2005GMO AMENDMENT BILL 2005
Amplify the provisions on risks assessmentsAmplify the provisions on risks assessments
Amend the liability determinations; Amend the liability determinations;
Amend the information requirements contemplated Amend the information requirements contemplated in the confidentiality clause;in the confidentiality clause;
Lay down criteria with regard to offences; Lay down criteria with regard to offences;
Provide for certain procedures during an appeal Provide for certain procedures during an appeal
processprocess
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SECTIONS OF THE BILL, 2005SECTIONS 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
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SECTIONS OF THE BILL, 2005 cntdSECTIONS 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
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SECTIONS OF THE BILL, 2005 cntdSECTIONS OF THE BILL, 2005 cntd
Section 5 - Duties of Council (must..)Section 5 - Duties of Council (must..)
• Type of assessments requiredType of assessments required
– Science-based risk assessmentScience-based risk assessment
– Risk management measuresRisk management measures
• Decisions (consensus) – facilities & activitiesDecisions (consensus) – facilities & activities
• Accidents – notification; emergency measuresAccidents – notification; emergency measures Section 5 - Powers of Council (may..)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
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SECTIONS OF THE BILL, 2005 cntdSECTIONS OF THE BILL, 2005 cntd
Section 7 – Functions of the RegistrarSection 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
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SECTIONS OF THE BILL, 2005 cntdSECTIONS 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
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SECTIONS OF THE BILL, 2005 cntdSECTIONS 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
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SECTIONS OF THE BILL, 2005 cntdSECTIONS OF THE BILL, 2005 cntd
Section 19 – appealSection 19 – appeal
• Time periodsTime periods
– Appeal board appointmentAppeal board appointment
– DecisionDecision
• Type of decisionsType of decisions
– Confirm, set aside, Confirm, set aside, substitutesubstitute, amend, amend
– Other order – minimize significant negative Other order – minimize significant negative impact on environment or human / animal impact on environment or human / animal healthhealth
• New scientific / technical evidence / information New scientific / technical evidence / information – directly applicable– directly applicable
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SECTIONS OF THE BILL, 2005 cntdSECTIONS OF THE BILL, 2005 cntd
Section 20 – RegulationsSection 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 House Biosafety Clearing House