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GMO AMENDMENT BILL 2005

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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 - PowerPoint PPT Presentation

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Page 1: GMO AMENDMENT BILL 2005

GMO AMENDMENT BILL 2005 GMO AMENDMENT BILL 2005

Page 2: GMO AMENDMENT BILL 2005

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INTRODUCTION TO GMO ACT (Act No. 15 of 1997)INTRODUCTION TO GMO ACT (Act No. 15 of 1997)

SAGENE: SAGENE: Advisory roleAdvisory roleResponsible for evaluation of risk assessment dataResponsible for evaluation of risk assessment dataAmendment of the Regulations of Agricultural Pest ActAmendment of the Regulations of Agricultural Pest Act

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 Executive CouncilEstablishment of Executive Council

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GMO ACT contGMO ACT cont

Act Infrastructure Act Infrastructure

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-- 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 contGMO ACT cont

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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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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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

TRADE POLICIES

ADMINISTRATIVE JUSTICE Promotion of Administrative Justice Act, 2000 Promotion of Access to Information Act, 2000

Page 7: GMO AMENDMENT BILL 2005

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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

Parliamentary process Parliamentary process

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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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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 (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

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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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Changes required from Protocol 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

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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

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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

• 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)

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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

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THANK YOU….THANK YOU….