DEA REGULATORY FRAMEWORK FOR GENETICALLY MODIFIED ORGANISMS (GMOs) GMASSURE Capacity Building Workshop 16-20/03/2015

Transcription

1 DEA REGULATORY FRAMEWORK FOR GENETICALLY MODIFIED ORGANISMS (GMOs) GMASSURE Capacity Building Workshop 16-20/03/2015

2 PRESENTATION OUTLINE Background Cartagena Protocol on biosafety Legislative framework in South Africa DEA s responsibilities Development of Environmental Risk Management Tools Post-market monitoring of GM crops Conclusion

3 BACKGROUND South Africa is a party to the Convention on Biological Diversity The Convention requires countries to developed the National Biodiversity Strategies and Action Plans (NBSAP) and National Biosafety Framework (NBF) as part of its obligations NBSAPs are the principal instruments for implementing the Convention at the national level as outlined in Article 6 of the Convention. NBSAP includes environmental biosafety issues: Ensures institutional co-operation and co-ordination to deal with potential risks from GMOs Develop and implement effective measures for management and control of potentially risky activities related to GMOs Share information and provide support to ensure adoption and implementation of highest biosafety standards to minimise risks associated with GMOs

4 CARTAGENA PROTOCOL ON BIOSAFETY Objective of this protocol is to help ensure the safe transfer, handling and use of LMOs that could have potential harmful effects on conservation and biodiversity (including human health). South Africa acceded to the Protocol in 2003

5 KEY ELEMENTS OF THE PROTOCOL Objective and scope Advance informed agreement LMO-FFPs Risk assessment and management Identification of LMOs (labelling) Information sharing; Biosafety Clearing House Capacity building Socio-economic considerations Liability and redress Compliance

6 INSTITUTIONAL ARRANGEMENT FOR THE MANAGEMENT OF THE CARTAGENA PROTOCOL ON BIOSAFETY National Competent Authority: Department of Agriculture, Forestry and Fisheries National Focal Point: Department of Environmental Affairs BCH Focal Point: Registrar of the GMO Act Overall Coordination mechanism: GMO Act Executive Council

7 BIOSAFETY FRAMEWORK FOR DECISION MAKING South Africa regulates all activities relating to GMO in terms of the Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997). Section 3 of the GMO Act makes provision for the establishment of an Executive Council, GMO Executive Council Overall Coordination mechanism of GMO in South Africa It is a decision making intergovernmental body which includes representatives from the Depts. of Agriculture Forestry and Fisheries, Science & Technology, Environmental Affairs, Health, Labor, Trade & Industry, supported by the Scientific Advisory Committee Duties: To advise the Minister of DAFF on all aspects concerning the development, production, use, application and release of GM Product To assess the potential Socio-Economic impact of the GM Product To communicate and interact with the public

8 LEGISLATIVE AND POLICY FRAMEWORK IN SOUTH AFRICA GMO Act (1997), as amended in 2006 to take into account CPB Provisions National Environmental Management Act (1998) National Environmental Management Biodiversity Act (2004) Foodstuffs Cosmetics and Disinfectants Act of 1972 (Health Dept.) National Bio Economy Strategy Public Understanding of Biotechnology Program (PUB), DST NRF

9 LEGISLATIVE AND POLICY FRAMEWORK IN SOUTH AFRICA (CONT.) NEMA Provides for: cooperative environmental governance by establishing principles for decision making on matters affecting the environment prohibition, restriction and control of activities which are likely to have a detrimental effect on the environment NEMA principles: Stipulates a risk-averse and cautious approach to avoid, minimize or remedy the disturbance of eco-systems and loss of biological diversity. Environmental management decisions should take into account the impact of decisions on all people, as well as promote participation of interested and affected parties, take place openly and transparently, and be appropriate in relation to the assessment of social, economic and environmental costs and benefits.

10 LEGISLATIVE AND POLICY FRAMEWORK IN SOUTH AFRICA (CONT.) NEMBA Provides for: the management and conservation of biodiversity within the framework of NEMA; The protection of species and ecosystems; Sustainable use of indigenous biological resources. Fair and equitable sharing of benefits arising from bio-prospecting of indigenous biological resources.

11 LEGISLATIVE AND POLICY FRAMEWORK IN SOUTH AFRICA (CONT.) Chapter 2; Section 11 (1)(b) of the Biodiversity Act SANBI must monitor and report regularly to the Minister on all categories of genetically modified organism post commercial release, based on research that identifies and evaluates risk Chapter 5; Section 78 of the Biodiversity Act If the minister has reason to believe that the release (trial or general release) of a GMO into the environment under a permit applied for in terms of the GMO Act may pose a threat to any indigenous species or the environment, no permit for such a release may be issued in terms of this Act unless an EIA has been conducted in accordance with Chapter 5 of NEMA as if such release were a listed activity contemplated in that chapter. The Minister must convey his/her belief to the issuing authority (DAFF) before the relevant permit is decided

12 DEA S RESPONSIBILITIES Assessing the environmental risk of the contained use of GMOs International negotiations and implementation of agreed national programmes on the environmental safety of GMOs Monitoring GMOs released into the environment Commissioning and disseminating scientific research on environmental aspects of GM

13 DEVELOPMENT OF ENVIRONMENTAL RISK MANAGEMENT TOOLS The development of Environmental Risk Assessments for GMOs aims to ensure an adequate protection of the environment from potential negative impacts of GMOs in the context of South African legislation. This is also in accordance to the strategic plan of the Cartagena Protocol on Biosafety, which states that Parties are required to facilitate the establishment and further development of effective biosafety systems for the implementation of the Protocol

14 APPROACH TO ENVIRONMENTAL RISK ASSESSMENT Environmental Risks Assessment is based on the NEMA principles It is carried out on a case-by-case basis If new information becomes available, risk assessment shall be reviewed Assessment of potential adverse effects on the environment associated with the management of GM crops is a requirement ERA applies to all GMO applications submitted under the GMO Act

15 ENVIRONMENTAL SAFETY ASSESSMENT CRITERIA Persistence and invasiveness Selective advantage or disadvantage Potential for gene transfer Interactions between the GM plant and target organisms Interactions of the GM plant with non-target organisms Effects on bio-geochemical processes and; Changes in agricultural practices

16 POST-MARKET MONITORING OF GENETICALLY MODIFIED CROPS Post-market monitoring of GMOs in South Africa is largely for compliance Permits issued also set conditions for post-market monitoring to be performed by permit holders Monitoring for compliance to permit conditions is carried out by inspectors within the Department of Agriculture Forestry and Fisheries (DAFF) In implementing the assigned role of NEMBA, the South African Biodiversity Institute (SANBI) is required to develop a monitoring system for post-market monitoring of GMOs in the environment Post commercial monitoring to be implemented under NEMBA will be targeted at hypothesis based research to serve as an early warning and as a system of oversight of biodiversity

17 CONCLUSION DEA uses a precautionary approach to the release of GMO s into the environment as informed by NEMA. Developing an effective management framework for GMOs is main priority Decision making is on the basis of a range of issues including national imperatives, socio-economic considerations, sound science and public input.

18 Mrs Wadzi Mandivenyi Mr Muleso Kharika Ms Thato Mogapi Mr Tondani kone Ms Ntakadzeni Tshidada