GMO AMENDMENT BILL 2005. 2 PRESENTERS Julian JafthaDoA Ben DurhamDST Leseho SelloDEAT Modiegi SelematselaDoH Ndivhou RabuliDoA Mbudzeni SibaraAdvisory

GMO AMENDMENT BILL 2005 GMO AMENDMENT BILL 2005

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PRESENTERSPRESENTERS

Julian Jaftha DoA

Ben Durham DST

Leseho Sello DEAT

Modiegi Selematsela DoH

Ndivhou Rabuli DoA

Mbudzeni Sibara Advisory Committee Chairperson

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ORDER OF PRESENTATIONSORDER OF PRESENTATIONS

Some general concerns • Precautionary Approach• Protection of indigenous seeds• Biotechnology in South Africa• Scientific safety assessments

GMO Amendment Bill• Environmental Impact Assessments• Labeling Regulations• Liability and Redress• Sections of the Amendment Bill

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PRECAUTIONARY APPROACH?PRECAUTIONARY APPROACH?

Principle 15 of Rio Declaration in 1992–

In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost effective measures to prevent environmental degradation

Lack of consensus on the status as a principle of law GMO Act: Implemented through risk assessment and

risk management Protocol: – Annex III

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PRECAUTIONARY APPROACH contPRECAUTIONARY APPROACH cont

Where decision is necessary, measures based on the precautionary approach should be:

• Proportional to risk• Non-discrimination • Consistent• Based on cost-benefit assessment• Subject to review• Capable of assigning responsibility for producing scientific

evidence

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Protection of the indigenous seedsProtection of the indigenous seeds

Farm saved seeds

Seed vigour

Not limited to GMO’s

Plant Breeders’ Rights Act

International Treaty on Plant Genetic Resources for Food and Agriculture

Policy on indigenous crops

Conservation

Collection, characterisation and storage of indigenous seeds

National Gene Bank

Seed diversity fairs

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BIOTECHNOLOGY IN SOUTH AFRICABIOTECHNOLOGY IN SOUTH AFRICA

DEPARTMENT OF SCIENCE AND

TECHNOLOGY

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SCIENTIFIC SAFETY ASSESSMENTSSCIENTIFIC SAFETY ASSESSMENTS

CHAIRPERSON

ADVISORY COMMITTEE

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ENVIRONMENTAL IMPACT ASSESSMENTENVIRONMENTAL IMPACT ASSESSMENT

DEPARTMENT OF ENVIRONMENTAL AFFAIRS AND TOURISM

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LABELING REGULATIONSLABELING REGULATIONS

DEPARTMENT OF HEALTH

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Foodstuffs, Cosmetics, Disinfectants ActFoodstuffs, Cosmetics, Disinfectants Act

Any person shall be guilty of an offence if he sells, manufactures, or imports for sale any foodstuffs, which is harmful or injurious to human health

Empowers the Minister to make regulations prescribing the manner in which foodstuffs shall be labelled.

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GM Food Labelling RegulationsGM Food Labelling Regulations

Regulations relating to the labelling of foodstuffs obtained through certain techniques of gene modification were published in 2004

Based on Codex Alimentarius principles for labelling, definitions and concepts

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Codex Alimentarius CommissionCodex Alimentarius Commission

“Food rules”was established in 1962, protect consumer health and facilitate trading practices

Codex Committee on Food Labelling developing guidelines on GM food labelling since 1995

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GM Food LabellingGM Food Labelling

Mandatory Requirements• A GM food differs significantly in composition, nutritional

value, storage, preparation

• The presence of allergen from crustaceans, eggs, fish, groundnuts, molluscs, soy beans, tree nuts and Triticum species

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Voluntary claim

• Genetically improved or enhanced characteristics– Validated and Certified by a body accredited to SANAS– Name of certifying body has to appear next to the claim

– Regulations governing the labelling and advertising of foodstuffs published under GN No. R2034 of October 1993

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Labelling of GM foods is not mandatory• Require product differentiation between GM and GM raw

materials prior to use in processing• Need for a certification system for monitoring and

verification• Threshold level of tolerance for commingling

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Australian study • 8-18% cost increase• Canada• 35-41% of the producer prices• The Philipines?

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No provision for non-GM claims Identity Preservation System

• Identity of a non-GM and products is preserved by segregating the handling and processing thereof from those of a GMO and its products

• SABS, Health, and Agriculture developing guidelines to provide for grains, fruit and vegetables, meat and fish and products thereof

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Current regulations can be regarded as interim measure pending the following

• Finalization of an Identity Preservation System• Progress at the Codex Committee on food labelling

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LIABILITY AND REDRESSLIABILITY AND REDRESS

DEPARTMENT OF AGRICULTURE

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LIABILITY AND REDRESSLIABILITY AND REDRESS

Existing liability regime• Common law• Gaps

Channeling of liability Type of liability

• Strict • Fault-based

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GMO AMENDMENT BILLGMO AMENDMENT BILL

DEPARTMENT OF AGRICULTURE

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Insert cartoon

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Section 1 – Definitions

Transboundary movement• cross border vs across boundaries

Contained use• Movement & storage

User • Consumer & end-user

Activity• Use

Commodity clearance• Relation to definition of release

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Section 5 – Powers and duties of the Council

Discretionary power• Different activities• Environmental release

– Public input, EIA, socio-economic impact– Regulations

Science based risk assessment• Convention on Biodiversity• Cartagena Protocol • Separate assessment for socio-economic impact

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Section 5 – Powers and duties of the Council

Public input• Conflict in time periods – GMO Act & PAIA• Access to information - What information is confidential?

– Provisions of the Protocol– PAIA as basis– Section 18

• Transparency– Feedback on decisions made– National Biosafety Clearing House

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Section 7 – Meetings of the Council

Consensus decision• Members present vs all members• Different sectors / policies / legislation• Effective decision-making

– Prior consideration– Meeting

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Section 9 – Functions of the Registrar

Too much power? Most functions subject to Council instruction Without instruction

• Maintain register – facilities & trial releases

• Routine inspections

• Suspects possible contraventions

– Cessation / dispose / repatriate

• Submit application & documents to Council

• Communicate Council decisions to Biosafety Clearing House

• Extension permits

– Subject to terms & conditions of Council

– Already previously approved

– Reporting to Council

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Section 10 – Composition of the Advisory Committee

Why specific requirement for ecologist?• Reason – Protocol

– Protection of the environment– Including human (and animal) health

• 1st level assessment - assess environmental, human and animal health concerns

Other experts less important?• Co-opting knowledgeable persons• Appointment of sub-committees

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Section 15 – Appointment of inspectors

Self regulation?• No independent review of assessments

– Advisory Committee function• No monitoring of compliance with permit conditions

– Routine inspections – section 16

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Section 19 – Appeal

Time periods?• Convening of Board• Taking decision• Communicating further action by Minister

The type of information to be considered in an appeal• Limited to “scientifically proven information”

Documents

GMO AMENDMENT BILL 2005. 2 PRESENTERS Julian JafthaDoA Ben DurhamDST Leseho SelloDEAT Modiegi SelematselaDoH Ndivhou RabuliDoA Mbudzeni SibaraAdvisory