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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
1…BIOTECHNOLOGY POLICY CONTEXT
2. LEGISLATION: GENETICALLY MODIFIED
ORGANISMS ACT, 1997 (ACT NO. 15 OF
1997) AND AMENDMENTS
5
2…GMOS: 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 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.
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 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.
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 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.
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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Briefing on South Africa's GMO Regulatory Framework

  • 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 1…BIOTECHNOLOGY POLICY CONTEXT
  • 5. 2. LEGISLATION: GENETICALLY MODIFIED ORGANISMS ACT, 1997 (ACT NO. 15 OF 1997) AND AMENDMENTS 5
  • 6. 2…GMOS: 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 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. 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 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. 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 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. 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