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100504genetically_0 (2).ppt

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Naila Shahid

This document provides a briefing on genetically modified organisms (GMOs) in South Africa. It discusses: 1) Background on biotechnology and GMOs, the country's biotechnology policy, and potential benefits of GMOs. 2) South Africa's GMO regulatory framework established through the GMO Act of 1997 and amendments aligning with international agreements. 3) The status of GMO crop adoption in South Africa, including which crops are approved and their economic impacts. 4) Procedures for imports and exports of GMOs regarding transboundary movement compliance with international protocols.

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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 2
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. 3 1... BIOTECHNOLOGY/ GMOs
National Biotechnology Strategy (2001) Promotes the establishment of a thriving biotechnology sector through 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 4 1BIOTECHNOLOGY POLICY CONTEXT
2. LEGISLATION: GENETICALLY MODIFIED ORGANISMS ACT, 1997 (ACT NO. 15 OF 1997) AND AMENDMENTS 5
2GMOS: SA REGULATORY LANDSCAPE 6 Department of Agriculture, Forestry & Fisheries Department of Environmental Affairs Department of Health Department of Science & Technology Department of Trade and Industry National Environmental Management Act, 1998 GMO Act, 1997 (Amendment in 2006) National Environmental Biodiversity Act, 2004 Convention on Biological Diversity/ Cartagena Protocol *Focal Point Foodstuffs, Cosmetics, and Disinfectants Act, 1972 CODEX Alimentarius Contact Point National Biotechnology Strategy 2001 Consumer Protection Act, 2008 Cartagena Protocol for Biosafety-2003 *Competent Authority
Implemented in 1999 - Ensure activities relating to GMOs are carried out RESPONSIBLY Limit adverse impact on environment, human/animal health How is this achieved? Administrative & consultative system Manage import, export, production, release & distribution Lay down criteria for risk assessment & risk management Ensure effective management of waste Prevent accidents 7 2...GMO ACT, 1997
Act makes provision for the Minister to appoint members to regulatory bodies which exercise oversight over the safety assessment and approval of GMO applications. 8 2...GMO ACT: REGULATORY INSTRUMENT Environmental Safety Food & feed safety Non safety issues e.g. trade & socio-economics Registrar (Administration) Executive Council Decision makers represented by DAFF, DEA, DoH, the dti, DoL, DST & AC Chair Advisory Committee Technical 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 9 2...International Obligations: Cartagena Protocol on Biosafety
Process of amending the Act was initiated in 2003 after SAs 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. 10 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 11 2... GMO Amendment Act (Act 23 of 2006)
3. STATUS OF GM CROP ADOPTION IN SOUTH AFRICA 12
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) 13 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
14 0 200 400 600 800 1000 1200 1400 1600 1800 2000 Hectares (x1000) Years Trends in South African hectares planted with GM maize WHITE YELLOW TOTAL (Source: ISAAA 2009)
15 3....IMPACT OF GM CROPS Economic benefits Less crop damage due to effective insect control Improved yields Reduced chemical use Savings on input costs Increased farm income Potential 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 16
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. 17
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 dtis 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. 18
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 dtis 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. 19
4. ..GM COMMODITY EXPORTS Same 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 Protocol GM status of maize consignment was declared to Kenya Import 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. 20
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. 21

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100504genetically_0 (2).ppt

  • 1. BRIEFING ON GENETICALLY MODIFIED ORGANISMS ACTING DIRECTOR GENERAL: MR PETER THABETE DEPARTMENT OF AGRICULTURE, FISHERIES AND FORESTRY
  • 2. 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 2
  • 3. 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. 3 1... BIOTECHNOLOGY/ GMOs
  • 4. National Biotechnology Strategy (2001) Promotes the establishment of a thriving biotechnology sector through 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 4 1BIOTECHNOLOGY POLICY CONTEXT
  • 5. 2. LEGISLATION: GENETICALLY MODIFIED ORGANISMS ACT, 1997 (ACT NO. 15 OF 1997) AND AMENDMENTS 5
  • 6. 2GMOS: SA REGULATORY LANDSCAPE 6 Department of Agriculture, Forestry & Fisheries Department of Environmental Affairs Department of Health Department of Science & Technology Department of Trade and Industry National Environmental Management Act, 1998 GMO Act, 1997 (Amendment in 2006) National Environmental Biodiversity Act, 2004 Convention on Biological Diversity/ Cartagena Protocol *Focal Point Foodstuffs, Cosmetics, and Disinfectants Act, 1972 CODEX Alimentarius Contact Point National Biotechnology Strategy 2001 Consumer Protection Act, 2008 Cartagena Protocol for Biosafety-2003 *Competent Authority
  • 7. Implemented in 1999 - Ensure activities relating to GMOs are carried out RESPONSIBLY Limit adverse impact on environment, human/animal health How is this achieved? Administrative & consultative system Manage import, export, production, release & distribution Lay down criteria for risk assessment & risk management Ensure effective management of waste Prevent accidents 7 2...GMO ACT, 1997
  • 8. Act makes provision for the Minister to appoint members to regulatory bodies which exercise oversight over the safety assessment and approval of GMO applications. 8 2...GMO ACT: REGULATORY INSTRUMENT Environmental Safety Food & feed safety Non safety issues e.g. trade & socio-economics Registrar (Administration) Executive Council Decision makers represented by DAFF, DEA, DoH, the dti, DoL, DST & AC Chair Advisory Committee Technical experts responsible for safety assessment
  • 9. 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 9 2...International Obligations: Cartagena Protocol on Biosafety
  • 10. Process of amending the Act was initiated in 2003 after SAs 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. 10 2... GMO Amendment Act (Act 23 of 2006)
  • 11. 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 11 2... GMO Amendment Act (Act 23 of 2006)
  • 12. 3. STATUS OF GM CROP ADOPTION IN SOUTH AFRICA 12
  • 13. 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) 13 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
  • 14. 14 0 200 400 600 800 1000 1200 1400 1600 1800 2000 Hectares (x1000) Years Trends in South African hectares planted with GM maize WHITE YELLOW TOTAL (Source: ISAAA 2009)
  • 15. 15 3....IMPACT OF GM CROPS Economic benefits Less crop damage due to effective insect control Improved yields Reduced chemical use Savings on input costs Increased farm income Potential 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:
  • 16. 4. STATUS REGARDING TRANSBOUNDARY MOVEMENT OF GMOS 16
  • 17. 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. 17
  • 18. 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 dtis 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. 18
  • 19. 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 dtis 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. 19
  • 20. 4. ..GM COMMODITY EXPORTS Same 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 Protocol GM status of maize consignment was declared to Kenya Import 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. 20
  • 21. 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. 21