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South African GMO Regulatory Framework: Ensuring Safe Biotechnology Practices

The Genetic Resources Department of Agriculture, Forestry, and Fisheries in South Africa outlines the regulatory framework for genetically modified organisms (GMOs) to ensure responsible import, export, production, and distribution. The Genetically Modified Organisms Act of 1997 aims to limit adverse environmental and health impacts, manage waste effectively, and minimize risks through rigorous assessment processes. The regulatory bodies appointed under this act oversee safety assessments and approvals for GMO applications, with expert committees evaluating applications based on scientific expertise in various fields such as nutrition, genetics, and ecology. The Executive Council, composed of representatives from different governmental departments, makes decisions based on recommendations from advisory committees. The framework also covers conditional commercial releases, commodity clearances, and field trials for GMO events. The application process involves public notifications, consultations, and compliance with safety and environmental standards. Overall, the framework emphasizes responsible biotechnology practices and engagement with stakeholders.

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South African GMO Regulatory Framework: Ensuring Safe Biotechnology Practices

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  1. Genetically modified organisms DIRECTORATE: GENETIC RESOURCES DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES 13 September 2013

  2. SA REGULATORY FRAMEWORK Department of Science & Technology Department of Agriculture, Forestry & Fisheries Department of Environmental Affairs Department of Health Department of Trade and Industry National Biotechnology Strategy 2001 GMO Act, 1997 (Amendment in 2006) National Environmental Management Act, 1998 Foodstuffs, Cosmetics, and Disinfectants Act, 1972 Consumer Protection Act, 2008 Cartagena Protocol for Biosafety-2003 *Competent Authority National Environmental Biodiversity Act, 2004 CODEX Alimentarius Contact Point Convention on Biological Diversity/ Cartagena Protocol *Focal Point

  3. GENETICALLY MODIFIED ORGANISMS ACT (Act No. 15 of 1997) Promulgated 1997 and implemented 1999 Objective – • ensure activities relating to GMO’s are carried out RESPONSIBLY • import, export, production, use, release & distribution • limit adverse impact on environment, human/animal health • effective management of waste • measures to evaluate & reduce potential risks • criteria for risk assessment

  4. REGULATORY PROCESS Act makes provision for the Minister to appoint members to regulatory bodies which exercise oversight over the safety assessment and approval of GMO applications. Registrar (Administration) • Environmental Safety • Food & feed safety • Non safety issues e.g. • trade & • socio-economics Advisory Committee Technical experts responsible for safety assessment Executive Council (EC) Decision makers represented

  5. ASSESSMENT PROCESS Application Advisory Committee Advisory sub-Committee Review Committee Chair: AC member Sub-committee members Executive Council TIMELINE FOR APPLICATIONS: 30-270 DAYS

  6. THE ADVISORY COMMITTEE SCIENTIFIC EXPERTISE • Nutrition • Pharmacology • Plant biochemistry • Plant breeding • Plant physiology • Poultry science • Proteomics • Vaccine development • Virology Agricultural biotechnology Allergenecity Bacteriology Biotechnology (medical/plant/veterinary/wine) Botany Ecology Entomology Food toxicology Genetics Microbiology Molecular biology

  7. THE ADVISORY COMMITTEE 7 AC (10 members, Ministerial Appointments) Sub-committee (54 members, appointed by Registrar) DUTIES: National Advisory Body Scientific experts Primary safety assessment of applications Subcommittee –more expertise Recommendation report to the EC

  8. EXECUTIVE COUNCIL • Appointed by DAFF Minister • Composition: DAFF, DEA, DST, the dti, DoH, DoL, DAC & AC Chair Duties: • Advise the Minister on all matters • Considering recommendation of AC decide on an application • Compliance to their respective mandates • Approve relevant guidance documents • Recommendations on appointment of members of AC • Consensus decision-making • Engagement with interest groups/ applicants: At EC’s request • Non-CBI minutes available to public

  9. GMO EVENTS APPROVED FOR CONDITIONAL COMMERCIAL RELEASE Use of event: importation/exportation, commercial planting and food and/or feed

  10. GMO EVENTS APPROVED FOR COMMODITY CLEARANCE Use of event: importation for food and/or feed

  11. GMO EVENTS APPROVED FOR FIELD TRIAL (2012/2013)

  12. ACTIVITIES REGULATED UNDER THE GMO ACT Import & Export Contained use (Activities in laboratories, greenhouse, glasshouse depending on containment levels) Trial release (Limited environmental release to provide for generation of SA data in different agro-ecological zones) General release (conditional) (Preceded by field trials, feeding studies, monitoring plan and annual reports) Commodity Clearance (conditional)

  13. COMMODITY CLEARANCES Use in food, feed and processing Only food/ feed safety data considered Special conditions for import: SABS standard • Limit environmental contact Asynchrony limits commodity imports: lack of segregation Imports usually for coastal regions

  14. COMMODITY CLEARANCE APPLICATION-DOW AGRO Application for commodity clearance of GM maize event DAS-40278-9, reference number Dow Agro Sciences -12/002 Short description of the genetic modification GM maize has been modified to be resistant to the herbicide 2, 4-dichlorophenoxyacetic acid (commonly referred to as 2,4-D). This trait is achieved through the expression of a protein (enzyme) in the maize which degrades 2.4D into herbicidally-inactive 2, 4-dichlorophenol (DCP). This means that in the production of the GM maize, a herbicide spraying regime may be applied which will not affect the GM maize.

  15. Public Notification Sunday Times, City Press & Rapport newspapers of 04 March 2012. Notices include: • Applicant • Type of Application • Origin of the inserted gene • Call for comments • Deadline for comments

  16. CONTD... Public notifications of the intended activity were placed in the Sunday Times, City Press and Rapport newspapers of 04 March 2012. Received by the Office of the Registrar 05 March 2012 No comments were submitted by the public ACB PAIA request -EC Decision document July 2012

  17. Thank you

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