GMO amendment Bill and biotech GMO amendment Bill and biotech policypolicy

W. De Greef, W. De Greef,

Consultant to AfricaBioConsultant to AfricaBio

The need to update the GMO Act 1997The need to update the GMO Act 1997

Need to adapt RSA legislation to Cartagena ProtocolNeed to adapt RSA legislation to Cartagena Protocol

Opportunity to:Opportunity to:– reflect on working of the GMO Actreflect on working of the GMO Act

– update structures and procedures update structures and procedures

– adapt to technology evolution adapt to technology evolution

Not much needed to be changed!Not much needed to be changed!

The purpose of biotech regulationThe purpose of biotech regulation

GMO biosafety regulation is put in place to ensure that GMO biosafety regulation is put in place to ensure that activities with GMOs are conducted safelyactivities with GMOs are conducted safely

It is neither a tool for promoting nor for blocking applications It is neither a tool for promoting nor for blocking applications of GM technologyof GM technology

South Africa and biotechSouth Africa and biotech

South Africa was one of the first developing nations to assess, South Africa was one of the first developing nations to assess, adapt and adopt GM crops for both commercial and adapt and adopt GM crops for both commercial and subsistence farming systems.subsistence farming systems.

The research system of South Africa has been a leader in The research system of South Africa has been a leader in applying GM technology on crops and traits of relevance to applying GM technology on crops and traits of relevance to third world agriculture.third world agriculture.

The regulatory system has ensured that this activity has The regulatory system has ensured that this activity has happened without any accidents happened without any accidents

The consequencesThe consequences

RSA is a leader in adapting biotech to serve its agricultural RSA is a leader in adapting biotech to serve its agricultural economyeconomy

It also rapidly becomes a leader in designing entirely new GM It also rapidly becomes a leader in designing entirely new GM crop solutions to African farming problemscrop solutions to African farming problems

RSA has most of the research capacity, and all of the farmer RSA has most of the research capacity, and all of the farmer experience with GM crops in Africa experience with GM crops in Africa

The regulatory environment in RSA will influence access to biotechnology for the entire

continent

The international contextThe international context

The Cartagena Protocol:The Cartagena Protocol:

CP and CBDCP and CBD

Art. 16 and 19 of the CBD put the CP in context:Art. 16 and 19 of the CBD put the CP in context:

– recognise the benefits that can be obtained from safe use of recognise the benefits that can be obtained from safe use of biotechnologybiotechnology

– While setting out the need to ensure that technology transfer be While setting out the need to ensure that technology transfer be properly regulated for safetyproperly regulated for safety

Relevant CBD articles

Relevant CBD articlesRelevant CBD articles

Relevant CBD articlesRelevant CBD articles

Comments on the BillComments on the Bill

Executive council:Executive council:– Composition,Composition,

– ActivitiesActivities

– ResponsibilitiesResponsibilities

– Consequences for RSA agricultural R&DConsequences for RSA agricultural R&D

LiabilityLiability

Composition Executive CouncilComposition Executive Council

Ensures multidisciplinary approach to the approval processEnsures multidisciplinary approach to the approval process

Inclusive in terms of participating government departments Inclusive in terms of participating government departments and agenciesand agencies

Set up to provide a one-door decision making process for the Set up to provide a one-door decision making process for the safe use and development of gene technology;safe use and development of gene technology;

The coordination role of ECThe coordination role of EC

Implies that decision procedures through the process set out in Implies that decision procedures through the process set out in Bill (and 1997 Act) are the sole entry point for GM decisionsBill (and 1997 Act) are the sole entry point for GM decisions

Concern: the coordination of decision making under GMO Act Concern: the coordination of decision making under GMO Act and NEMA Act and Biodiversity Act.and NEMA Act and Biodiversity Act.– Possibility of parallel decision makingPossibility of parallel decision making

– Need for clear agreement on role of the different ActsNeed for clear agreement on role of the different Acts

The consequences of parallel regulation:The consequences of parallel regulation:– Confusion for actors in R&D and in farmingConfusion for actors in R&D and in farming

– Possibility of divergent decisions Possibility of divergent decisions loss of credibility loss of credibility

Substitution of Section 5 of 1997 ActSubstitution of Section 5 of 1997 Act(section 4 of the Bill)(section 4 of the Bill)

Most of the new text intends to translate obligations vs. The Most of the new text intends to translate obligations vs. The CP into national law.CP into national law.

Concerns:Concerns:– Provisions of section 4g-4j of the BillProvisions of section 4g-4j of the Bill

– Text of section 4mText of section 4m

Impact on:Impact on:– Working of farming sector with approved GM seed and commodity Working of farming sector with approved GM seed and commodity

cropscrops

– The future working of South African researchers, particularly in The future working of South African researchers, particularly in international cooperationinternational cooperation

4g – 4j and farming4g – 4j and farming

High probability of transboundary movement of seed and High probability of transboundary movement of seed and commodity grain produced or sold in RSA commodity grain produced or sold in RSA

becomes becomes de factode facto illegal illegal

Reason is NOT that these products may be dangerous, but the Reason is NOT that these products may be dangerous, but the large gap in regulatory readiness between RSA and its large gap in regulatory readiness between RSA and its neighboursneighbours

Precedents:Precedents: Argentina Argentina Brazil Brazil

China China several neighbours several neighbours

RSA takes on a lot of liability there without having the tools RSA takes on a lot of liability there without having the tools for pre-emptive action to avoid the issuefor pre-emptive action to avoid the issue

4m and transboundary movements4m and transboundary movements

Section 4(m): Section 4(m): where the Council has been informed by the registrar that there where the Council has been informed by the registrar that there is a reasonable suspicion that an activity is conducted contrary to this Act or to is a reasonable suspicion that an activity is conducted contrary to this Act or to a condition contained in a permit issued under this Act, determine—a condition contained in a permit issued under this Act, determine—

(i) a place or facility whereto a genetically modified organism used in such a (i) a place or facility whereto a genetically modified organism used in such a activity or any material or substance used, affected or potentially affected activity or any material or substance used, affected or potentially affected by such activity must be removed; andby such activity must be removed; and

(ii) appropriate measures for the (ii) appropriate measures for the disposal or repatriationdisposal or repatriation of any genetically of any genetically modified organism used in such activity or any material or substance used, modified organism used in such activity or any material or substance used, affected or potentially affected by such activity.affected or potentially affected by such activity.

Does this work both ways?Does this work both ways?

If so, does RSA take on responsibility for policing all its If so, does RSA take on responsibility for policing all its borders for exports?borders for exports?

Section 4 and research cooperationSection 4 and research cooperation

Does not address needs for international research cooperationDoes not address needs for international research cooperation– This reflects the silence of the Cartagena Protocol on the same issueThis reflects the silence of the Cartagena Protocol on the same issue

– Uses single procedure for experimental and commercial materialsUses single procedure for experimental and commercial materials

Consequence:Consequence:– Rapid decline in international movements of Rapid decline in international movements of experimentalexperimental GM GM

materialsmaterials

– Decline in international cooperation and technology transfer Decline in international cooperation and technology transfer

– No resources allocated to research community to comply with the very No resources allocated to research community to comply with the very stringent demands of regulatorsstringent demands of regulators

In contradiction with CBD and CP objectives on technology transfer

Section 17 (Act): LiabilitySection 17 (Act): Liability(section 11 of the Bill)(section 11 of the Bill)

Pre-empts outcome of CP negotiations on Liability and Pre-empts outcome of CP negotiations on Liability and RedressRedress

Commits RSA to the outcome before knowing the shape of the Commits RSA to the outcome before knowing the shape of the agreementagreement

Is this really necessary? Is this really necessary?

Consequences:Consequences:– Most R&D for developing world happens in public researchMost R&D for developing world happens in public research

– Has South Africa considered the impact of ALL possible outcomes of Has South Africa considered the impact of ALL possible outcomes of the L&R debate on its national research policy?the L&R debate on its national research policy?

The impact of the Cartagena ProtocolThe impact of the Cartagena Protocol

Assessing the consequences of making the Assessing the consequences of making the text of the CP part of the GMO Acttext of the CP part of the GMO Act

Assessment timeAssessment time

CP only deals directly with transboundary movements, CP only deals directly with transboundary movements, but:but:

De FactoDe Facto standard for national regulations standard for national regulations

Need to assess its assumptions and consequencesNeed to assess its assumptions and consequences– Impact on technology transferImpact on technology transfer

– Impact on cost and effectiveness of public researchImpact on cost and effectiveness of public research

Need to assess the impact on RSA’s position as:Need to assess the impact on RSA’s position as:– A leading agricultural nation of the SouthA leading agricultural nation of the South

– A leading technology developer and adapter in agricultureA leading technology developer and adapter in agriculture

Need to foresee financial and operational tools to exercise Need to foresee financial and operational tools to exercise leadership in Africa and developing worldleadership in Africa and developing world