South Africa has put in place measures for the effective implementation of its obligations under the Cartagena Protocol on Biosafety, such include both legal and administrative instruments. There are approximately 21 permanent staff members in the various government Departments serving on the GMO Act Executive Council. The following legal frameworks and guidelines have been developed: • Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997) which makes provision for the establishment of an Executive Council, an intergovernmental decision-making body. This Act, which is the principal legislation for the regulation of GMOs was amended to fully align the SA legislation to the Protocol (GMO Amendment Act, 2006 (Act No. 23 of 2006). • National Environmental Management Act, 1998 (Act No. 107 of 1998) (provides for environmental impact assessment of selected categories of GMOs) • National Environmental Management Biodiversity Act, 2004 (Act No. 10 of 2004) (provides for long term monitoring of potential impacts of GMOs in commercial production) • Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) (deals with safety standards as well as labelling of certain class of foodstuffs derived from GMOs) • Consumer Protection Act, 2008 (Act No. 68 of 2008) (deals with labelling of GMOs) In addition, several guidelines have also been developed to support the implementation of the biosafety framework in South Africa, which include: • Environmental Risk Assessment Framework for genetically modified plants: a guidance document (2008) • ERA Framework for GM Pharmaceuticals • ERA Framework for GM Fish • Guidance on compositional analysis and feeding studies data requirements for commodity clearance and general release applications, with emphasis on stacked events • Guideline for submission of annual reports for certain activities undertaken in terms of the GMO Act, 1997 • Guidelines for compiling a public notification • Guideline for submission of time extension requests for current permits issued under the GMO Act • Standard operating procedures with regard to regulation 4 of the GMO Act • Standard operating procedures with regard to regulation 2(2) of the GMO Act • Guidelines for working with genetically modified organisms • Guidelines for use by the Advisory Committee when considering applications South Africa’s second generation National Biodiversity Strategy and Action Plan for the period 2015-2025 has also incorporated biosafety related activities including monitoring and reporting on the impacts of Genetically Modified Organisms on biodiversity. The budget allocation for Biosafety is mainly supported through the National Treasury systems.

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, LMOs which are pharmaceuticals to humans would also be assessed by the Department of Health (the South Africa Health Products Regulatory Authority).

Contained use of LMOs is regulated under the GMO Act; and implemented through provisions in the GMO Act Regulations (R No. 120 of 2010). However, GMO’s used under conditions of contained use for research and academic purposes, at containment levels 1 and 2 within a facility registered in accordance with the GMO Act; are exempted from the requirement of a permit in terms of the regulations. A contained use permit is required once the research is scaled up from basic research to product development, or when the containment level is above 2. SA has a transit policy, this policy holds that LMOs may only transit the territory of SA to another country if the receiving country confirms their acceptance of the consignment.

The GMO Act provides for the decision-making for the first and subsequent transboundary movement of LMOs. All GMO applications are subjected to a multidisciplinary process of scientific evaluation. The Advisory Committee (AC), comprising of scientific experts is responsible for the evaluation of risk assessment data of all applications, following which a recommendation is submitted to the Executive Council (EC). Decision to permit an activity or not is done by the Executive Council (EC), an inter-governmental decision-making body. The EC considers the recommendations of the AC, compliance with various policies and comments from members of the public or interested parties. The decision-making process (especially timelines) is impacted by the following: a) The involvement of different government departments b) The legal prescript of consensus decision-making c) Inadequate information provided by the applicants. d) The potential impact of new scientific information which needs to be assessed.

The GMO Act provides for the decision-making for LMOs intended for direct use as food or feed, or for processing. All GMO applications are subjected to a multidisciplinary process of scientific evaluation. The Advisory Committee (AC), comprising of scientific experts is responsible for the evaluation of risk assessment data of all applications, following which a recommendation is submitted to the Executive Council (EC). Decision to permit an activity or not is done by the Executive Council (EC), an inter-governmental decision-making body. The EC considers the recommendations of the AC, compliance with various policies and comments from members of the public or interested parties. The decision-making process (especially timelines) is impacted by the following: a) The involvement of different government departments b) The legal prescript of consensus decision-making c) Inadequate information provided by the applicants. d) The potential impact of new scientific information which needs to be assessed

The GMO Act stipulates that the GMO Act Executive Council, may reconsider any decision taken by it if it receives new and relevant scientific or technological evidence about activities conducted in terms of the GMO Act, which may have an impact on the risk assessment and risk management measures, public input, environmental impact assessment or socio-economic aspects. In the current reporting period, South Africa has not reconsidered a decision taken regarding an intentional transboundary movement of an LMO. The GMO Act also makes provision for an appeal to be lodged against a decision taken in terms of the GMO Act, in which case an appeal board appointed on a case-by case, in terms of this Act may confirm, set aside, substitute or amend the decision which is subject to the appeal, taking into consideration new scientific or technical evidence or any other information that is in the opinion of the appeal board, directly applicable to the appeal.

South Africa/Swaziland: Training course to capacitate the wide spectrum of risk assessors within the national biosafety regulatory system of Swaziland with the necessary knowledge and skills that will allow them to effectively assess GMOs and make accurate and confident regulatory decisions. South Africa /Sudan Joint biosafety risk analysis training course to capacitate the Sudanese risk assessors with the necessary knowledge and skills that will allow them to effectively assess GMOs and make accurate and confident regulatory decisions. Hosted by DST (bilateral co-operation Africa) and presented on their request by BSA. “South Africa / Ethiopia joint technical workshop on biotechnology”. South Africa participated in the NEPAD-Agency First Consultative Meeting on Regulatory Capacity Building in Southern Africa on the Gene Drive held in Botswana from 24-28 June 2017 focusing on application of the gene drive technology in inducing male sterility in Aedes egypti mosquito for reducing mosquito populations and thereby reducing malaria transmission. South Africa participated during the second African Biosafety leadership Summit held on 17-18 August 2018 in Nairobi, Kenya which focused on the gene drive technology as a potential biocontrol tool for vector-borne diseases in Sub-Saharan Africa and other relevant issues to be discussed at COP-MOP 9. South Africa/Kenya high level consultative meeting held in 2017 to share country experience with Kenyan Boards, CEOs and top technical officers in the key regulatory agencies. South Africa participated in a training workshop organised by NEPAD Agency, in collaboration with the African Union Commission, on “Negotiation Skills and Techniques” as part of the Africa region’s preparations towards the ninth Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP 9) from September 4 – 6, 2018 in Addis Ababa, Ethiopia. The purpose of the workshop was to strengthen skills of African Negotiators, to exchange information, views and experiences on key agenda items for MOP 9 South Africa participated in the BIO Africa Convention, held on 27 to 29 August 2018 in Durban, South Africa. The Convention, which was organised by Africa Bio in partnership with the Department of Science and Innovation, was the first of its kind biotechnology indaba to be held in Africa to provide a platform for dialogue and discussion with stakeholders in the global biotechnology environment and showcase Africa’s biotechnology innovations in the health, agriculture and industrial sectors to the global world and brings the global world to explore investments, collaborations and partnerships with the African biotech business leaders, entrepreneurs, researchers, regulatory authorities and policy makers. The programme featured presentations from various South Africa stakeholders including industry, regulators, researchers South Africa participated in an expert group meeting held in 2016 in Washington, USA, with the purpose of reviewing the the work of the Ad hoc Technical Expert Group on Risk Assessment for LMOs under the Cartagena Protocol for Biosafety.

In 2018, South Africa embarked on a process to develop a Regional Engagement Strategy for Biosafety with the objective to strengthen South Africa’s contribution to the region’s biosafety efforts by providing support to African countries, based on expressed needs and through various platforms, in setting up and implementing National Biosafety Frameworks (NBF). The Strategy consists of a vision which is “Effective and clear policies on the regulation of modern biotechnology across Africa to ensure sustainable use and protection of biodiversity, while enhancing trade, food security and cooperation in biosafety”. The strategy is guided by the four SOs as outlined below: • SO1: Support the development and implementation of National Biosafety Frameworks; • SO2: Strengthen capacity for regulating GMOs; • SO3: Promote regional dialogue on biosafety; and • SO4: Facilitate information sharing

South Africa developed “Environmental Risk Assessment Framework for genetically modified: a guidance document” in 2008. Other supplementary guidance include: • Risk analysis of contained use research and development activities with genetically modified aquatic organisms in South Africa (2011); • Environmental Risk Assessment Framework: Guidance Document for Genetically Modified Plant-Made Pharmaceuticals (2016) (unpublished); In 2016, SA initiated the review of the ERA framework which will also incorporate the problem formulation phase of ERA. Initiated parallel to this, is the process of defining assessment endpoints for use in ERA of GMOs in South Africa. Genetically Modified Organisms approved for commercial release are released under a conditional general release permit where permit holders are required to conduct some case specific monitoring for a certain period of time to confirm the findings of the ERA. This is further supported through the long term impact based monitoring mandated through the National Environmental Management: Biodiversity Act.

South Africa is required to take measures ensuring that LMOs subject to intentional transboundary 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 fulfilled. These are: • A letter indicating the intent of the potential exporter • Completed application forms • Payment of appropriate fees in terms of the GMO Act • Notification of the country of import into whose environment the LMO will be introduced intentionally • Affidavit from applicant • Acknowledgement and confirmation by the Party of Import to the intended introduction of the LMO to its environment. However failure by the Party of Import to acknowledge receipt of a notification shall not imply its consent to the proposed import. • A permit for exportation is only issued if the Registrar of the GMO Act has received written consent (original) from the Party of Import or via the potential exporter. The export permit will contain at least the following information:  Identification of the LMO (relevant traits/characteristics of the LMO);  Requirements for the safe handling, storage, transport and use;  Contact details for further information on the exporter, the importer; and  A declaration that the transboundary movement is in accordance with the Protocol’s requirements. The GMO Testing Facility (University of the Free State) has the necessary infrastructure for the detection and identification of LMOs. The lab is certified to perform GM detection. In addition, the GMO Testing Facility at University of the Free State) has standard operating procedures for laboratory sampling as well as the detection of LMOs. In addition to the University of Free State facility, in 2016, a new state of the art facility referred to as the SciCorp Laboratories was established in South Africa. The facility is currently accredited to conduct qualitative and quantitative GMO testing. This is a private laboratory facility that meet the scientific and laboratory testing needs of the agricultural and food industries.

The Department of Agriculture, land and Rural Development (DALRD) is the Competent National Authority and administers the GMO Act. The GMO Act provides for an administrative system through which authorizations for any activity involving GMOs are granted through the issuance of the relevant permit. The GMO Act makes provision for the appointment of a Registrar, two regulatory bodies i.e. the Advisory Committee, Executive Council. All GMO applications are subjected to a multidisciplinary process of scientific evaluation. The Advisory Committee (AC), comprising of scientific experts is responsible for the evaluation of risk assessment data of all applications, following which a recommendation is submitted to the Executive Council (EC). Decision to permit an activity or not is done by the Executive Council (EC), an inter-governmental decision-making body. The EC considers the recommendations of the AC, compliance with various policies and comments from members of the public or interested parties. The Department of Environmental of Environment, Forestry and Fisheries is the National Focal Point (NFP).

The Registrar of the GMO Act is currently the National Focal Point for the BCH. South Africa currently utilises the Global BCH and the website of the Department of Agriculture, Land Reform and Rural Development as information sharing platforms. Information that is currently on the global BCH include national laws and regulations, previous national reports, Annex 3 Risk Assessments and decisions taken on commodity clearance and general release applications. The risks assessments that are made available on the Central Portal are the non-confidential business annex III risk assessments submitted by applicants. The development of a format to capture decisions on risk assessments for publishing on the BCH is in progress. South Africa is currently participating on the UNE-GEF BCH phase 3 project titled “UNEP-GEF Project for Sustainable Capacity Building for Effective Participation in the BCH”. The project include 3 capacity building workshops and the establishment of a national BCH. Two capacity building workshops have been held to date and a total of 52 people were trained during the workshops, including regulators, researchers, students, industry, traders, civil society, non-governmental organisations, and public entities.

In South Africa, the GMO applications are submitted in two versions with confidential business information (CBI) and non-confidential business information. The non-CBI is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA). Non-Confidential Business Information copy (NON-CBI copy), is a copy where any information that is regarded as confidential business information is deleted. Section 18 of the GMO Act provides that the following information shall not be kept confidential: (a) The general description of the GMOs, the name and address of the applicant, and the purpose of the contained use or release and the location of use; (b) The methods and plans for the monitoring of the GMOs and for emergency measures in the case of an accident. The summary of scientifically based risk assessment of the impact on the environment and human and animal health.

1) The White Paper on Science and Technology (1996) notes that the development of the National System of Innovation (NSI) requires a society that values and understands science and technology as social tools; 2) The Bio-economy Strategy (2013) advocates for ‘initiatives to promote public understanding of the technologies; 3) GMO Act also makes provision for the Public notification of proposed release or commodity clearance of genetically modified organisms. All the outreach programmes and certain publication may be accessed through the http://biosafety.org.za/ and all information related to regulatory activities in SA are found under the following webpage: www.daff.gov.za/daffweb3/Branches/Agricultural-Production-Health-Food-Safety/Genetic-Resources/Biosafety. As aforementioned, South Africa has developed the Regional Engagement strategy which amongst other elements advocated for capacity building within the Africa region. It’s second strategic objective is to: Strengthen capacity for regulating GMOs: this objective seeks to build confidence in the regulation of modern biotechnology by strengthening capacity in conducting risk assessments and risk management and biosafety research by convening and supporting regional capacity building workshops. To this end South Africa in partnership with the CBD Secretariat and with the support from the Government of the Republic of Korea through the Korea Biosafety Capacity-Building Initiative, organized a training course on risk assessment in Pretoria, South Africa from 8 to 12 April 2019. The objective of the workshop was to provide theoretical and hands-on training for Anglophone African countries on: (a) The risk analysis and risk assessment processes (concepts, methodology, key issues to considered); (b) Problem formulation approach (hypothesis formulation, risk scenarios); and (c) Hands-on training in the evaluation of case studies of living modified organisms for environmental release. In addition, the University of Free State has been providing technical expertise support & advice towards the implementation of the Multi Country Project to strengthen Institutional Capacities on LMO testing in Support of National Decision Making (MCP-ICLT). The MCP-ICLT is a multi-country GEF project involving 6 countries in southern Africa and RAEIN-Africa is the Lead Executing Agency for this project that aim at capacitating selected laboratories on sampling, documentation and LMO detection. The project involves 6 ministries from the partner countries; • Angola - Ministry of Environment of Angola (MINAMB); • Democratic Republic of Congo (DRC) - Directorate of Sustainable Development, Ministry of Environment, Nature Conservation and Tourism; • Lesotho - Ministry of Tourism, Environment and Culture (MTEC); • Madagascar - General Directorate of Environment, Ministry of Environment, Ecology and Forests; • Malawi - Environmental Affairs Department, Ministry of Natural Resources, Energy and Environment; • Mozambique - The Agriculture Research Institute of Mozambique (IIAM) South Africa also participate as resource people on the Southern African Network of GM Detection Laboratories (SANGL) which is a voluntary sub regional network of laboratories for LMO detection. Participating countries include Angola, Botswana, DRC, Lesotho, Madagascar, Malawi, Mozambique, Namibia, Swaziland, Tanzania, Zambia and Zimbabwe. Furthermore The GMO Testing Facility (University of the Free State) has participated in workshops as resource person at the “Harmonisation of GMO Analysis” carried out by the Joint Research Centre (JRC) of the European Commission in the frame of the DG SANTE 'Better Training for Safer Food Programme (BTSF)”. The African Centre for Biodiversity and the Third World Network jointly convened a workshop in Durban, South Africa, from 29-31st March 2019. The workshop was attended by delegates from South Africa, Tanzania, Cote d ‘Ivoire, Burkina Faso, Mali, Mozambique, Malawi, Uganda, Nigeria, Swaziland, Kenya, Germany, United Kingdom, Philippines. These included resource experts, delegates from farmer organisation, a donor organisation, as well as non -governmental/farmer support organisations. A total of 33 participants attended the workshop with, 19 Females and 14 Males.

The SA biosafety (including socio-economic considerations) process is designed to ensure alignment with national policy/regulation, through representation by several government departments in the decision-making committee. Hence unless a socio-economic impact study is triggered (i.e. commissioned, reported and published), this process is not designed to be a peer-reviewed process. However, the South African regulatory framework, through the GMO Act seeks to provide measure to promote the responsible development, production, use and application of LMOs. In this, decision-making takes into consideration various aspects including biosafety of LMOs to humans and the environment as well as socio-economic considerations. Socio-economic considerations are informed by a number of elements and South Africa, through the Department of Science and Innovation have developed a Bio economy Strategy in 2013 which advocates the adoption of science and technology, including exploitation of modern biotechnology, to address the country’s socio-economic development goals of poverty reduction and improved quality of life, while ensuring continued economic growth. In addition, the Bio-economy Strategy’s objective for agriculture is to strengthen agricultural biosciences innovation to ensure food security, enhance nutrition and improve health, as well as enable job creation through the expansion and intensification of sustainable agricultural production and processing. These interventions should be driven by strategic need as well as market demand. The strategy also advocates for biotechnology research and utilisation of skills and solutions emerging from the research to be effectively transferred to emerging, small-scale and commercial farmers. It further calls for Science councils and universities to respond by developing human capacities and technological capabilities; and industry should participate directly to guide and extract value from developments and to create new, globally competitive products that create jobs and wealth and improve the quality of life of South Africans.

South Africa is currently not a party to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The GMO Act which is the principal law regulating activities with GMOs has provisions on liability which stipulates that liability for damage cause by activities relating to a GMO shall be borne by the “user” concerned, where user means a person who conducts an activity with a GMO. The Consumer Protection Act of the Republic of South Africa is a piece of legislation which provides for liability where damage is caused by goods including GMOs or products thereof. Section 61 of the CPA covers all the four elements mentioned above. Firstly, with regard to damage, the CPA provides that: “Harm for which a person may be held liable in terms of this section includes – (a) The death of, or injury to, any natural person; (b) An illness of any natural person; (c) Any loss of, or physical damage to, any property, irrespective of whether it is movable or immovable; and (d) Any economic loss that results from harm contemplated in paragraph (a), (b) or (c) NEMA creates a liability regime for addressing environmental damage, however, certain issues remain unconsidered. In particular, the matter of financial security remains unaddressed. NEMA does not take into account the possible breadth of claims that might arise and the resultant costs that may be associated with clean-up and restoration, the scale of which certainly necessitates the provision of a financial mechanism.

Genetically Modified Organisms developed through modern biotechnology are recognised as important potential contributors to efforts towards addressing sustainable development challenges. Such include the 17 sustainable development goals (SDGs) which are integrated to balance the dimensions of sustainable development, namely, economic, social and environmental, with poverty eradication, changing unsustainable and promoting sustainable patterns of consumption and production, and protecting and managing the natural resource base of economic and social development as the overarching objectives of sustainable development. Modern biotechnology offers a range of tools which are able to deliver useful products or offer effective solutions in major sectors of the economy, including agriculture, health, food and environment. The technology can also contribute to the Africa regions efforts towards attaining the 7 aspirations of the African Union Agenda 2063 wherein some of the priority areas identified include: increased agricultural production, development driven by science, technology and innovation as well as conservation and sustainable use of biodiversity. The Southern African Development Community (SADC) Protocol on Science, Technology and Innovation also seeks to “foster co-operation and promote, the development, transfer and mastery of science, technology and innovation in Member States” as outlined in Article 2 of this Protocol.