DIRECTORATE: GENETIC RESOURCES DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES 13 September 2013 G ENETICALLY MODIFIED ORGANISMS

SA REGULATORY FRAMEWORK 2 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 Cartagena Protocol for Biosafety-2003 *Competent Authority National Biotechnology Strategy 2001 Consumer Protection Act, 2008

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 3 GENETICALLY MODIFIED ORGANISMS ACT (Act No. 15 of 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. 4 REGULATORY PROCESS Environmental Safety Food & feed safety Non safety issues e.g. trade & socio-economics Registrar (Administration) Executive Council (EC) Decision makers represented Advisory Committee Technical experts responsible for safety assessment

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

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

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

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

GMO EVENTS APPROVED FOR CONDITIONAL COMMERCIAL RELEASE  Use of event: importation/exportation, commercial planting and food and/or feed 9 CompanyCropTraitYear approved Monsanto, Syngenta and Pioneer Maize Insect resistance Herbicide tolerant (4) 2007, 2010, 2012 Herbicide tolerant(2)2002, 2010 Insect resistance (3)1997,2003, 2010 MonsantoCotton Insect resistant Herbicide tolerant (2) 2005, 2007 Insect resistant (2)1997, 2003 Herbicide tolerant (2)2000 MonsantoSoybeanHerbicide tolerant (1)2001

GMO EVENTS APPROVED FOR COMMODITY CLEARANCE  Use of event: importation for food and/or feed 10 CompanyCropTraitYear approved Monsanto, Syngenta Dow AgroScience and Pioneer Maize Insect resistance Herbicide tolerant (19) 2002, 2003, 2004, 2011, 2012 Herbicide tolerant (4)2011,2012 Insect resistance (8)2011 BayerCottonHerbicide tolerant (1)2011 AgrEvo, Dow AgroScience, BASF and Pioneer SoybeanHerbicide tolerant (6)2013, 2012, 2001 BayerRice Herbicide tolerant (1) 2011

GMO EVENTS APPROVED FOR FIELD TRIAL (2012/2013) 11 CompanyOganismTrait Triclinium Wits Vaccines TB HIV Syngenta, Pioneer and Monsanto Maize Insect resistance Herbicide tolerant (9) Male fertility Female infertility (1) BayerCotton Insect resistance Herbicide tolerant (1)

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)

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

COMMODITY CLEARANCE APPLICATION-DOW AGRO  Application for commodity clearance of GM maize event DAS , 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. 

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

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

Thank you 17