BRIEFING ON GENETICALLY MODIFIED ORGANISMS

ACTING DIRECTOR GENERAL: MR PETER THABETE

DEPARTMENT OF AGRICULTURE, FISHERIES AND FORESTRY

OUTLINE OF BRIEFING

1. BACKGROUND INFORMATION ON BIOTECHNOLOGY/ GENETICALLY MODIFIED ORGANISMS (GMOs)

2. LEGISLATION: GENETICALLY MODIFIED ORGANISMS ACT, 1997 (ACT NO. 15 OF 1997) AND AMENDMENTS

3. STATUS OF GM CROP ADOPTION IN SOUTH AFRICA

4. STATUS REGARDING TRANSBOUNDARY MOVEMENT OF GMOS

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Defining Biotechnology

• A “toolbox” of various techniques that uses living organisms or derivatives thereof to modify or make useful products. In the past this has included selective breeding for improvement of plants and animals and the fermentation of commodities such as bread, beer, wine, cheese etc

Defining Modern Biotechnology

• Discovery of genetic code or “DNA” biotechnology applications were able to facilitate the transfer of genetic material within and beyond the species boundaries thus allowing living organisms to be modified or altered at a genetic level, resulting in what is known as a genetically modified organism (GMO).

• Collectively this process is termed genetic engineering/ modification and represents but one of the many tools in the biotechnology “toolbox”.

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1... BIOTECHNOLOGY/ GMOs

National Biotechnology Strategy (2001)

Promotes the establishment of a thriving biotechnology sectorthrough various interventions because of potential to contribute to

economic development.

Biotechnology Opportunities• increase agricultural production in a sustainable manner• address production challenges relating to limited arable land and the

declining natural resource base.• Nutritionally enhanced food

CAUTION!

GM technology not solution to every problem but instead should be considered in combination with other sustainable technologies and existing agricultural practices

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1…BIOTECHNOLOGY POLICY CONTEXT

2. LEGISLATION: GENETICALLY MODIFIED ORGANISMS ACT, 1997 (ACT NO. 15 OF 1997) AND AMENDMENTS

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2…GMOS: SA REGULATORY LANDSCAPE

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Department of Agriculture, Forestry & Fisheries

Department of Environmental

AffairsDepartment of Health

Department of Science &

Technology

Department of Trade and

Industry

NationalEnvironmentalManagement

Act, 1998

GMO Act, 1997(Amendment in

2006)

NationalEnvironmental

Biodiversity Act, 2004

Convention onBiological Diversity/Cartagena Protocol *Focal Point

Foodstuffs, Cosmetics, and Disinfectants

Act, 1972

CODEX AlimentariusContact Point

National Biotechnology

Strategy2001

Consumer Protection Act, 2008

CartagenaProtocol for Biosafety-2003*Competent Authority

Implemented in 1999 - Ensure activities relating to GMOs are Implemented in 1999 - Ensure activities relating to GMOs are carried out carried out RESPONSIBLYRESPONSIBLY

Limit adverse impact on environment, human/animal healthLimit adverse impact on environment, human/animal health

How is this achieved?How is this achieved?

Administrative & consultative systemAdministrative & consultative systemManage import, export, production, release & distributionManage import, export, production, release & distributionLay down criteria for risk assessment & risk managementLay down criteria for risk assessment & risk managementEnsure effective management of wasteEnsure effective management of wastePrevent accidentsPrevent accidents

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2...GMO ACT, 1997

Act makes provision for the Minister to appoint members to Act makes provision for the Minister to appoint members to regulatory bodies which exercise oversight over the safety regulatory bodies which exercise oversight over the safety assessment and approval of GMO applications.assessment and approval of GMO applications.

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2...GMO ACT: REGULATORY INSTRUMENT

•Environmental Safety•Food & feed safety•Non safety issues e.g. trade & socio-economics

Registrar(Administration)

Executive CouncilDecision makers represented by DAFF, DEA,

DoH, the dti, DoL, DST & AC Chair

Advisory CommitteeTechnical experts responsible for safety

assessment

Cartagena Protocol on Biosafety is an international agreement established under the Convention on Biological Diversity

Objective: contribute to ensuring an adequate level of protection for the safe transfer, handling and use of GMOs to limit adverse effects on conservation and biodiversity, also taking into account risks to human health.

SA acceded to the Protocol in 2003

Obligations as a Contracting Party to provide legal, administrative and other measures to implement provisions of Protocol

DAFF is the recognized Competent Authority and DEA is the Focal Point

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2...International Obligations: Cartagena Protocol on Biosafety

Process of amending the Act was initiated in 2003 after SA’s accession to the Cartagena Protocol on Biosafety

Amendments focused on alignment with provisions of Protocol and related environmental legislation

GMO Amendment Bill subjected to parliamentary processes and was approved by President in April 2007.

In 2008 regulations were drafted and gazetted for public input.

Following review and consultation of comments, regulations were finalized and submitted for approval in 2009.

In February 2010 Amendment Act was proclaimed and the regulations gazetted for implementation.

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2... GMO Amendment Act (Act 23 of 2006)

Status of implementing key amendments to the Act:

Procedures already in place to address transboundary movement of GMOs in compliance with Protocol

Protocol provisions for risk assessment and risk management already implemented

Consultation with related government departments on environmental and socioeconomic impact assessments is ongoing

Development of official biosafety clearing house is near completion Administrative processes initiated to facilitate inclusion of

representation on EC from Arts and Culture, Water Affairs and Forestry

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2... GMO Amendment Act (Act 23 of 2006)

3. STATUS OF GM CROP ADOPTION IN SOUTH AFRICA

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3. STATUS OF GM CROP ADOPTION IN SA

SA AREA PLANTED WITH GM CROPS

Total Maize = 78% of total maize ha

White maize: hectares, 64% crop Yellow maize: hectares, % crop

Soybean: 85% crop

Cotton: 92-95% crop

Total Area : 2,1 million hectares

(ISAAA, 2009)

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Crop Trait Year approved

Cotton

InsectR HerbT 2005, 2007

HerbT 2000, 2007

InsectR 1997, 2003

Maize

InsectR HerbT 2007

HerbT 2002

InsectR 1997, 2003

Soybean HerbT 2001

GM Crops – Commercially Approved

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(Source: ISAAA 2009)

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3....IMPACT OF GM CROPS

Economic benefits

Less crop damage due to effective

insect control Improved yields Reduced chemical useSavings on input costsIncreased farm incomePotential benefits for both small scale

and commercial producers

Cumulative benefits from 1999-2009

estimated at $500 mill for SA (ISAAA, 2009)

Source: Gouse et al (2003, 2004, 2005)

BT Maize:

BT Cotton:

4. STATUS REGARDING TRANSBOUNDARY MOVEMENT OF GMOS

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4. STATUS REGARDING TRANSBOUNDARY MOVEMENT OF GMOS

Imports/ Exports procedures applicable to: GM seed for intentional introduction into the environment i.e. For planting GM Commodity for direct use as food, feed or processing (not planting)

Procedures strictly comply with Protocol requirements (Articles 7,8,11 & 18)

Generally follows a process involving- Notification of GM events in the consignment Decision making based on available risk assessment data of GM events Communication of decision and issuance of relevant authorisation documents

if appropriate.

Challenges where contracting Parties to the Protocol are at different levels of implementation and do not yet have all the required procedures in place.

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4. ...STATUS OF GM COMMODITY IMPORTS In 2005, Executive Council (EC) suspended all existing and new

applications for commodity imports of GM maize.

Decision based on the dti’s concerns regarding the possible negative impact of GM commodity trading on local producers.

To facilitate decision making a study was commissioned by the EC to investigate the issues raised by the dti.

Outcomes of the study broadly confirmed that restricting access to new GM maize events would disadvantage both domestic producers and consumers of GM maize.

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4. ..STATUS OF GM COMMODITY IMPORTS (cont.) Following an analysis of the study report the dti recommended to the EC that:

Imports of GM maize commodity be allowed only if DAFF is able to ensure adequate control measures for policing and monitoring of commodity imports.

Import of GM sugarcane not be allowed unless verification is possible through scientific testing.

Consultation with SACU member states on the development of regulatory measures for GM commodities due to potential risks of transboundary movement of GM products to SACU countries.

In response to the dti’s recommendations the EC has commissioned several interventions to address strengthening of regulatory control measures.

Since EC decisions are consensus based, the Council is currently awaiting the final position by the dti on whether they are satisfied that their concerns have been addressed.

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4. ..GM COMMODITY EXPORTSSame consideration given to SA for commodity imports needs to be extended to importing Parties when SA is the exporting country.

GM maize exports to Kenya:Both Kenya and SA are Parties to the ProtocolGM status of maize consignment was declared to KenyaImport authorisation was issued by Kenya accepting the consignment Export permit issued by SA for mixed consignment of GM maize to Kenya for use as a commodity (i.e. not for planting)Follow ups with Kenyan government regarding status of maize consignment resulted in response from KEPHIS that shipment of maize was transferred to a warehouse.No official communication received since media reports.

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CONCLUDING REMARKS To date SA has made significant progress with the alignment and

implementation of its Biosafety Regulatory Framework

Because the regulatory framework in SA cannot function within a vacuum we have to take cognizance of Agreements and Protocols that apply at an International level in the interest of ensuring our trade credibility for accessing international markets.

We do acknowledge the challenges relating to GMOs in so far as different countries expressing different viewpoints on the subject and being at different levels of regulatory implementation.

Continue to engage our regulatory counterparts on technical issues relating to GMOs in an attempt to address some of the identified challenges.

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