GMOs in South Africa: A Regulatory Perspective Chantal Arendse Director: Biosafety

2 What is a Genetically Modified Organism? Organism whose genetic material has been altered/ modified in a manner that does not occur naturally through multiplication or natural recombination How?  Inserting a specific gene  Switching a gene on or off  Removing a specific gene

3 What are the potential risks? Food, animal feed and health safety issues  Allergenicity  Toxicity  Pathogenicity  Digestibility Environmental safety issues  Gene flow and Biodiversity  Invasiveness/Weediness/Resistance  Impact on subsoil and other ‘non-targeted’ organisms  Gene variability / Instability  New pests and diseases.

4 What is Biosafety? GMOs Risks Biosafety: Provides for risk management measures to avoid risks to human, animal health and environment resulting from GMOs

5 GMO Timeline in SA SAGENE 1990’s GM Cotton/ Maize 1997

6 What does it mean to regulate GMOs? Responsibility: Objectively evaluate the scientific evidence, on a case by case basis and make decisions relating to GMO activities in the best interest of the environment, human & animal health. Pro-GMO Stakeholders Anti-GMO Stakeholders

7 National Environmental Management Act, 1998 SA Legislation SA Legislation GMO Act 15, 1997 (Amendment,2007) National Environmental Biodiversity Act, 2004 Convention on Biological Diversity / Biosafety Protocol Foodstuffs, Cosmetics, and Disinfectants Act, 1972 (Act 54 of 1972) CODEX Alimentarius Cartagena Protocol on Biosafety 2003 National Biotechnology Strategy Department of Agriculture Department of Environmental Affairs and Tourism Department of Health Department of Science & Technology

8 Genetically Modified Organisms Act (Act No. 15 of 1997) Implemented in Ensure activities relating to GMOs Implemented in Ensure activities relating to GMOs are carried out RESPONSIBLY How is this achieved? Implement measures:  Including import, export, production, release & distribution  limit adverse impact on environment, human/animal health  Lay down criteria for risk assessment  Measures to evaluate & reduce potential risks  Ensure effective management of waste  Prevent accidents

9 GMO Amendment Act (Act 23 of 2006) Scope Amend and add definitions Amend composition of EC (incl. DWAF, DAC) Facilitate the administrative procedures of the Act Amplify the duties of the EC, AC & Registrar Clarify application process Risk assessment in line with new legislation Procedures during appeal process Alignment with provisions of Cartagena Protocol on Biosafety & other legislation such as Biodiversity Act, 2004  Amendment process initiated in 2002/3 and included consultations and public hearings.  Approved by President in April 2007  Amendment regulations published for comments – March 2008

10 GMO Act : Regulatory Instrument Registrar Advisory Committee (AC) Executive Council (EC) Appointed by Minister Administration Instructions by EC (applications & permits) Ensure Compliance Appoint inspectors National Advisory Body Primary safety assessment of applications Scientific experts Subcommittee –more expertise & capacity GMO Decision Makers DoA (Chair), DST, DEAT, DoH, the dti, DoL, AC Chair (DAC & DWAF) Decisions – consensus based TIMELINE FOR APPLICATIONS: DAYS

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12 What are some of the burning issues regarding GMO regulation?

13 Does GM Food need to be labelled? The DoH, Directorate: Food Control is the sole regulatory authority on labelling of genetically modified food; Regulations Relating to the Labelling of Foodstuffs Obtained Through Certain Techniques of Genetic Modification No. R25 of 2004 [Foodstuffs, Cosmetics, and Disinfectants Act, 1972 (Act 54 of 1972)] Labelling regulations consider nutritional and safety aspects;  Must Label foodstuff significantly different in respect of the composition, nutritional value, mode of storage, preparation or cooking, allergenicity or human or animal origin  May label for enhanced Characteristic Claim must be validated by certified body CODEX – International committee on food labelling - awaiting outcome of decision regarding labeling of GM foods Use of terminology: “GM Free” vs “Non GM” under consideration

14 SOCIO ECONOMIC CONCERNS GM Technology raises concerns relating to the impact on the livelihoods of emerging farmers and rural communities in the developing world The specific concerns of GM crop adoption in developing countries relates to:  Monopoly on the price of the GM seeds  dependency on new generation of GM seeds  GM Crops are not suitable and do not address the needs of developing countries  possible loss of existing traditional varieties and indigenous technologies, thereby reducing the diversity, flexibility and resilience of indigenous farming systems Most of these concerns are not unique to GM crops. Cartagena Protocol on Biosafety – Article 26: Focuses on the impact in terms of the value of conservation and biological diversity to indigenous and rural communities

15 PRECAUTIONARY PRINCIPLE Cartagena Protocol on Biosafety: Article 10 What does it mean? Lack of scientific certainty regarding the extent of potential harm to the environment is not a valid ground for refraining from taking a decision, which could include preventative measures. Provisions of the precautionary principle have been adopted in the decision making procedures contained in the GMO Act (& Amendment).

16 ACCESS TO INFORMATION Biowatch Court Case (2004): Court ruling in February 2005 that information relating to the administration of the Act should be provided but confirmed that DoA still has a responsibility to protect confidential business information. In terms of Promotion of Access to Information Act (PAIA): access to non confidential business information. Departmental website: BIOSAFETY CLEARING HOUSE – a provision of the Biosafety Protocol -Represents a web based information portal to facilitate exchange of information. -The national BCH web portal is in the final stages of development. Interaction with media: All media requests be directed via the office of the Chief of Communications

17 PUBLIC NOTIFICATION  Intention to introduce GMOs into the environment.  Notification includes: Information of applicant, objective of activity, description of the GMO and description of the intended release site.  Facilitates access to the non-confidential copy of the application for interested parties to submit comments to the Registrar.  Comments and the responses from applicants are considered by the EC during the decision making process.  Improvements to public notification is being considered in terms of the amendment regulations.

18 GMOs in South Africa…..the last 10 years?

19 GMOs Approved for Commercial use Type of approval: General release – conditional Use of the event: Importation/exportation; commercial planting; food and/or feed CompanyCropTraitYear approved Monsanto Cotton Insect R Herb T 2005, 2007 Herb T 2000, 2007 Insect R 1997, 2003 Maize Insect R Herb T 2007 Herbicide tolerant 2002 Insect resistant1997 Soybean Herbicide tolerant 2001 SyngentaMaizeInsect resistant2003

20 SA Area planted with GM crops 2007 White maize: 1, 040 million hectares, 62% crop Yellow maize: hectares, 52% crop Soybean: hectares, 80% crop Cotton: hectares, 90% crop (90% small scale farmers) Total Area : 1,8 million hectares (Source: Clive James, ISAAA 2007)

21 GMO Activities approved? Trial Approvals CropsVaccines Maize (Drought T ) Tuberculosis & HIV Sugarcane (antimicrobials) Potato (Insect R ) Contained Use (linked to facility) –GM bacteria producing amino acids –Sweet potato (Insect R ) –Cassava (improved starch content) Registered Facilities across the country

22 GMOs & the Wine Industry GM Vine field Trials – Institute for Wine Biotechnology, US Objective: Long term stability and expression of transgenes Application still pending GM Malolactic Wine Yeast Application not approved Guidelines and standards for the use of GMOs in wine production still under consideration by the International Organisation of Wine and Vine (OIV) Impact on export markets

23 GMOs: Looking towards the future?

24 Global Area (Million Hectares) of Biotech Crops, 2007: by Country

25 Thank You