Plant biotechnology helps farmers tackle insects, diseases, and weeds in the fields, as well as other environmental conditions such as drought. This increases the survival and yields of the crops. In the future biotech crops could offer foods with higher nutrient levels, longer shelf life and the ability to grow, even in the face of climate change. South Africa is ranked first in Africa and ninth globally as the mega-biotech country on the basis of the number of hectares of biotech crops under cultivation. The economic gains from biotech crops for South Africa is estimated to be over US$218.5 million. Only three biotech crops are currently cultivated in South Africa.
Biotech crops have enabled farmers worldwide to boost the profitability, productivity, and sustainability of their farms. This helps to create a better quality of life for their communities by improving the local economy, providing customers with high-quality nutritious crops, and protecting the natural environment. Biotech crops have already provided farmers with agricultural innovation they never thought possible. The future promises even greater progress.
The biotech industry is one of the most cautiously regulated industries in the world. Biotech products must meet an exhaustive series of regulatory requirements to ensure environmental and human safety before they are released onto the market.
A number of national and international regulations govern the use of genetically modified organisms (GMOs) in South Africa. The aim of these regulations is to ensure that any activity with GMOs is assessed for potential risks to human health and the environment prior to undertaking any such activity. Furthermore, it aims to ensure that approved activities are conducted in a controlled manner including, if necessary, strategies to mitigate any potential risks.
The regulation of GMOs is principally governed by the Genetically Modified Organisms Act (GMO Act) and its subsequent amendments and their applicable regulations. South Africa ratified the Cartagena Protocol on Biosafety in 2003. This protocol is focused specifically on regulating the transboundary movement of LMOs (living modified organisms), which are GMOs capable of transferring or replicating genetic material, to minimise the potential risks posed by LMOs by ensuring the safe transfer, handling, and use of LMOs that may have negative effects on biodiversity or on human health.
AfricaBio continues to advocate on behalf of the industry and members who trade on GM-derived products. That is why we work with closely with policy makers and regulators at national and provincial spheres of government – to keep them apprised of the impact of existing or proposed regulations on our industry. Some of these laws and regulations can have profound effects on our ability to effectively meet the needs of the millions of people who rely on our products every day. For this reason, we develop technical positions on existing or proposed laws or regulations. Some of the highlights of AfricaBio interventions in this area include: Addressing regulatory hurdles and working on projects aimed at improving the regulatory environment such as:
• Supporting the implementation of the National Bio-economy
• Development of technical papers to address the data requirement for stacks products
• Post Market Motoring Addressing the liability clauses on permit conditions & split responsibility between tech developers and grain traders
• Post Market Monitoring: Coordination and facilitation of harmonised post-market monitoring plan on behalf of the industry
• Engagement with the food value chain to ensure alignment and practical GM product labelling regulations
• Supporting product stewardship to ensure the responsible and sustainable use of biotechnology.
AfricaBio’s strategic objective is to deliver high-quality strategic programmes and services to its members and the Biotechnology community, by advocating for an efficient policy and a regulatory environment that promotes the safe and effective use of biotechnology. Our advocacy programmes provide support for AfricaBio members in policy and sector development. We regularly engage with government officials and policy-makers on issues affecting the biotechnology sector in South Africa and the region. AfricaBio has developed policy briefs (which can be found under resources for members) addressing key policy issues on biotechnology in South Africa and the region.
POST-MARKET MONITORING (PMM)
GMO commodity clearance applications are granted and regulated under a permit issued as per the GMO Act no. 15 of 1997. In accordance with Article 2(1) of the Regulations, no person shall import, use, or distribute imported GMO commodities not approved for general release without the appropriate permit. Article 1.3 of the permit conditions for commodity clearance requires the permit holder to provide the operators with information regarding the safety and general characteristics of the GMO; actions to be undertaken in case of significant accidental grain spillage; the possible consequences that may arise from accidental environmental release as a result of spillage during the discharge, handling, transit and transportation process; and inform operators who handle and process bulk mixtures of imported GM commodities that the event has received commodity clearance approval.
Article 1.7 of the permit conditions requires the permit holders to submit an annually report to the Office of the Register that include any information received from operator regarding their experience on the handling and use of GM commodity and information on the performance of the event in the countries where it is commercially grown, especially focusing on any adverse effect on human and animal health and the environment.
AfricaBio facilitates the coordination of PMM on behalf of its members. We collate the information from traders, compile an annual report and submit it to the Registrar of the GMO Act on behalf of its members.
PRODUCT INFORMATION FOR GRAIN TRADERS
GMO commodity clearance applications are granted and regulated under a permit issued as per the Genetically Modified Organisms Act 15, 1997 (GMO Act no. 15 of 1997). In accordance with Article 2(1) of the Regulations, no person shall import, use, or distribute imported GMO commodities not approved for general release without the appropriate permit. Article 1.3 of the permit conditions for commodity clearance requires the permit holder to provide the operators with the following information:
the safety and general characteristics of the GMO;
actions to be undertaken in case of significant accidental grain spillage;
the possible consequences that may arise from accidental environmental release as a result of spillage during the discharge, handling, transit and transportation process; and
Inform operators who handle and process bulk mixtures of imported GM commodities that the event has received commodity clearance approval.
Article 1.7 of the permit conditions require the permit holders to submit an annually report to the Office of the Register that include the following:
any information received from operator regarding their experience on the handling and use of GM commodity;
information on the performance of the event in the countries where it is commercially grown, especially focusing on any adverse effect on human and animal health and the environment.
The scope of this monitoring framework covers the authorization of commodity approvals for import, processing, food and feed use in South Africa under the GMO Act, 15 of 1997. It excludes authorization for the general release (cultivation) of the equivalent commodity approvals and seed products into the South African environment.
Nevertheless, the permit holder has an obligation to indicate methods and monitoring plans of the GMO event and indicate any emergency procedures that need to be applied in the event on an accident.
Permit holders are not directly involved in the import and trade of GM commodities; their involvement being limited to farm level. Post-harvest grain from different varieties (and events) is initially co-mingled by millers, remaining in this state throughout the value chain. Thus a post-market monitoring plan for GM commodities needs to be conducted in collaboration with third parties, such as operators, involved in their import, handling and processing. Grain traders are routinely exposed to the imported commodities and are the best placed to monitor and report any unexpected incidents within the framework of their routine surveillance of the commodities they handle and use.
To facilitate and ensure oversight of their GM events, the Technology Developers have, through AfricaBio, engaged the grain traders to collaborate in implementing this post market monitoring plan. AfricaBio, as an independent stakeholder association, is best suited to liaise between the Technology Developers and traders who potentially handle their co-mingled events .
Traders on the other hand, must submit applications for import of GM commodities. A part of this initiative will therefore provide easy access to information necessary to fulfill this task. This initiative has been endorsed by the regulators.
PRODUCT INFORMATION FOR COMMODITY CLEARANCE APPROVAL