South Africa regulates all activities relating to genetically modified organisms (GMOs) in terms of the Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997) which is administered by the Department of Agriculture, Forestry and Fisheries (DAFF). Section 3 of the GMO Act makes provision for the establishment of an Executive Council, an intergovernmental body which includes representation from the departments of Agriculture, Forestry and Fisheries, Arts and Culture (DAC), Science and Technology (DST), Environmental Affairs (DEA), Trade and Industry (the dti), Labour (DoL) and Health (DoH). The Executive council is the decision making body. In addition to the GMO Act, South Africa also has the following pieces of legislation that considers biosafety issues:<br />1) National Enviromental Management Act 107 of 1998 (provides for environmental impact assessment of selected categories of LMOs)<br />2) National Environmental Management Biodiversity Act 10 of 2004 (provides for long term monitoring of potential impacts of LMOs)<br />3) Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 (deals with safety standards as well as labelling of certain class of foodstuffs derived from LMOs)

The transboundary movement of pharmaceuticals which are LMOs is managed like any other activity. The regulatory framework allows for a cross-sectoral assessment of all activities, as a result, pharmaceuticals for humans would also be assessed by the Department of Health and the Medicines Control Council. <br />In addition, South Africa is in a process of developing a guidance document for the Environmental Risk Assessment (ERA) Framework for Pharmaceutical crops (Pharma Crops).

Decisions regarding contained use or transit have not been communicated to the BCH. South Africa's communication has been limited to decisions on the general/commercial release and commodity clearance.

The GMO Act provides for decision making for the first and subsequent transboundary movement of the LMOs within periods consistent with provisions of the Protocol. <br />Furthermore, the GMO Act in South Africa provides for the establishment of regulatory bodies namely: the Advisory Committee (AC) and the Executive Council (EC). The AC is composed of independent scientists with various scientific backgrounds and is responsible for the review of applications and advising the EC as to the level of risk associated with proposed activities and whether a permit for that particular activity can be issued. This may include risk management strategies that may need to be implemented should the permit application be approved. <br /><br />The decision making process (especially timelines) is impacted by the following:-<br />a. The involvement of different government departments.<br />b. The legal prescript of consensus decision making.<br />c. Inadequate information provided by the applicants.<br />d. The potential impact of new scientific information which needs to be assessed.<br />e. New developments or GM events where the regulatory authority may have limited experience

Applications considered under the GMO Act are required to be accompanied by a risk assessment which is considered by the Advisory Committee (AC) and the Executive Council (EC). The AC evaluates the applicant's risk assessment and management measures, and advises the EC on the adequacy of the recommended risk management measures. The EC takes the recommendations of the AC into consideration during decision making. Permits issued include risk management measures that the permit holders must comply with. <br /><br />Monitoring of GMOs in South Africa is two fold: 1) The Department of Agriculture, Forestry and Fisheries monitors contained use and field trial activities. Monitoring of GMOs commerically released into the environment is conducted by the South African National Biodiversity Institute as provided for in Chapter 2 of the National Environmental Management Biodiversity Act.<br /><br />In order for applications to be considered compliant under the GMO Act, one of the requirements is the completion of the risk assessement. Two risk assessment documents are submitted for the purpose of evaluation by the regulatory authorities, one being a comprehensive environmental risk assessment document that covers all the requirements for South Africa, and the other being a risk assessment as outlined in Annex 3 of the Cartagena Protocol on Biosafety.<br /><br />National Treasury annualy approves tariffs for services rendered by government. All applications under the GMO Act are subjected to such tariffs; however, most of the costs associated with processing of applications are covered by the government.

The current legislation provides for the Executive Council, a decision-making body consisting of various government departments which serves as a mechanism to implement emergency measures in case of unintentional transboundary movement.

South Africa is required to take measures ensuring that LMOs subject to intentional transboundary&nbsp; movement (exports) are accompanied by documentation identifying the LMOs and providing contact details of persons responsible for such movement. The details of these requirements vary according to the intended use of the LMOs but require that certain basic requirements be fulfiled. These are:<br />1. A letter indicating the intent of the potential exporter<br />2. Completed application forms<br />3. Payment of appropriate fees in terms of the GMO Act<br />4. Notification of the country of import into whose environment the LMO will be introduced<br />5. Affidavit from the applicant on the accuracy of the information submitted&nbsp; <br />6. Acknowledgment and cofirmation by the Party of Import to the intended introduction of the LMO to its environment.<br />A permit of exportation is only issued if the Registrar of the GMO Act has received written consent from the Party of import or via the potential exporter. The export permit will contain at least the following information:<br />1. Identification of the LMO (relevant traits/characteristics of the LMO)<br />2. Requirements for the safe handling, storage, transport and use<br />3. Contact details for further information on the exporter and the importer<br />South Africa only allows importation from countries which have same or less number of GMO events approved or commercialised

The Department of Agriculture, Forestry and Fisheries is the Competent National Authority responsible for the administration of the Cartagena Protocol on Biosafety whereas the Department of Environmental Affairs is the National Focal Point of the Protocol.

Applications are submitted in two formats: 1) confidential business information which is limited to regulators only and 2) the non-Confidential Business Information (NON-CBI) which is made available&nbsp; for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA).

1. AfricaBio hosts delegations from various African countries including Kenyan farmers, regulators, journalists, cereal milling associations, and seed traders. <br />2. Support has been provided by a number of training workshops in which instruments of government and other players were involved such as:<br />- Biosafety South Africa &amp; Regional Agricultural and Environment Initiatives Network–Africa (RAEIN Africa): Malawi-20 trained; Zimbabwe- 25 trained and Zambia-25 trained<br />- Biosafety South Africa &amp; GMASSURE: Pretoria- 41 trained, Namibia- 37 trained and Zimbabwe- 40 trained<br />- Biosafety South Africa and African Biosafety Network of Expertise (ABNE):&nbsp; Kenyan regulators - 25 trained<br />- Biosafety South Africa and the Department of Science and Technology:&nbsp; Zimbabwean regulators -50 trained<br />- Uganda Bilateral meeting 29 July 2013<br />- Namibia bilateral meeting held 27 October 2014<br />- African Biosafety Network of Expertise (ABNE) Study Tour Program for African Regulators, June 4 – 11, 2014, Pretoria, South Africa (Uganda, Ethiopia, Malawi, Mozambique, Zimbabwe, Kenya, Ghana and Togo)<br />- Agric-Biotech &amp; Biosafety Conference 2014 Southern African 4-5 March 2014 Sheraton hotel, Pretoria

The Public Understanding of Biotechnology (PUB) programme and Biosafety South Africa which are entities of the Department of Science and Technology (DST). The PUB aims to ensure a clear, balanced understanding of the scientific principles, related issues and potential of biotechnology and to stimulate public debate around its applications in society. Biosafety South Africa supports innovation in biotechnology by ensuring the development of safe, sustainable biotechnological products

The public is notified of all intentional environmental releases through a public notification placed in newspapers, (or other means) circulating in the area where the intended release is due to take place. Applicants are required in terms of the GMO Act to submit two sets of Risk Assessments: the Confidential Business Information (CBI) and Non-CBI copy of an application which is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA). It is worth noting that public inputs are taken into consideration in the decision-making process.<br />In South Africa there are a number of public awareness initiatives that are conducted by various institutions including the Biotechnology Industry Association. Such initiatives include:&nbsp; Agri-youth Indaba, Farmers Agric Expo; Exhibition at the Rand Easter Shows; Journalists Business breakfast, national newspaper, national radios and TV adverts. Such platforms provide opportunities for the public and participants to network, share information and to improve knowledge concerning the safe transfer, handling and use of living modified organisms in relation to the conservation and sustainable use of biological diversity, also taking into account risks to human health.

South Africa took a decision to reject an application for general (commercial) release of genetically modified potato into the South African market. The decision to reject the application was not necessarily taking into account the impact of living modified organisms on the conservation and sustainable use of biodiversity. The reason for rejection was based on risk assessment and economic considerations

In order to adequately prepare for the signing and ratification process, a specialist study was commissioned in 2012 to assess the impact of the Nagoya-Kuala Lumpur Supplementary Protocol on South Africa. This was informed by the fact that the regulation of GMOs in South Africa is overseen by a number of state entities. As a result, the implications required extensive input from a number of core sector departments.