CROSS-SECTOR
STUDENT CHAPTER
REGULATORY MATTERS
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.
Insect-resistant maize was first grown in South Africa in 1998. Now herbicide-tolerant and double-stacked herbicide-tolerant/insect-resistant maize are grown in South Africa. Statistics of 2015 indicated that 87% of maize cultivated in South Africa is GM maize. The double-stacked, herbicide-tolerant/insect-resistant maize accounts for the greatest proportion of GM maize grown.
Herbicide-tolerant soybean has been grown since 2001. In 2015, it accounted for approximately 92% of the total area of cultivated soybean. South Africa's soybean production reached 508 000 tonnes in the 2014/15 production season. The South African soybean industry was negatively affected by the drought. Nevertheless, the industry has grown significantly with potential for further growth.
Insect-resistant cotton was the first GM crop grown in South Africa in 1997. Now herbicide-tolerant cotton and double-stacked, herbicide-tolerant/insect-resistant cotton are also grown. Statistics in 2014/15 showed that virtually no conventional cotton is grown in South Africa. The double-stacked, herbicide-tolerant/insect-resistant cotton accounts for more than 95% of cotton planted.
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.
BT/HT MAIZE DEMONSTRATION RESEARCH TRAILS IN SA
The aim of this project is to conduct BT-maize demonstration trials for emerging farmers within the different provinces of SA. This project demonstrates the role of agricultural biotechnology in protecting crops, increasing yields, and generating income. The BT-maize demonstration trials help farmers, policymakers, regulators, the general public in South Africa, and the region to understand and accept biotechnology. The Gauteng Department of Agriculture and Rural Development (GDARD) and other Provincial departments of Agriculture promote public understanding of biotechnology through these demonstration trial units (DTUs) and farmer-training in biotechnology communication.
FEASIBILITY STUDY TO EXAMINE EXISTING MARKETS AND POTENTIAL MARKET DEMAND FOR NEW AND UNDERUTILISED CROPS AND VALUE ADDITION
The aim of this project is to conduct a feasibility study to examine the existing markets and potential market demand for new and underutilised crops including their value addition. Results from the market analysis will provide information and recommendations to direct R&D investment in agricultural infrastructure that can facilitate value addition and agro-processing. It is envisaged that this exercise will enable the Department of Science and Technology (DST) to make informed decisions on where to direct funding resources. The feasibility study in this area will assist in fulfilling the Bio-economy Agricultural Implementation Plan targets.
REVISION OF THE BIOTECHNOLOGY STRATEGY FOR GAUTENG TO BE ALIGNED WITH THE NATIONAL BIO-ECONOMY STRATEGY
The aim of this project is to review the 2007 Gauteng Biotechnology Strategy to evaluate its impact and relevance; revise and align the strategy with the National Bio-economy Strategy; enhance the competitiveness of Bio-economy sectors through research and innovation; enable the Gauteng Department of Agriculture and Rural Development (GDARD). The further aim 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" in alignment with the objective of the National Bio-economy Strategy. This will impact the support of GDARD in achieving its vision of "vibrant, equitable, sustainable rural communities, food security for all, protected and enhanced environmental assets, and natural resources" thereby addressing the South African National Development Plan Mid-Term Strategic Framework (NDP MTSF) outcomes 7 and 1.
DUAL-TECHNOLOGY DEMONSTRATION TO EMERGING FARMERS: BT/HT WHITE MAIZE
AfricaBio conducted a pilot project on a multifaceted approach, assisting in mitigating agricultural challenges by introducing sustainable agricultural technologies like round-up-ready crops and pest-resistant crops to help small-scale and emerging farmers in the country to increase their yield in a sustainable manner. In this, AfricaBio is introducing small scale farmers to BT-HT white maize, demonstrating the benefits of agricultural biotechnology to the farmers, building their capacities, as well as enhancing food security in the target communities by demonstrating the role of conservation agriculture for sustainable crop production.
AG BIOTECH COMMUNICATION AND OUTREACH
AfricaBio partnered with the USDA-FAS Pretoria office to intensify efforts on awareness creation, and increase factual AgBiotech communication and outreach in South Africa and in Zambia. The aim of the project was to increase the understanding and acceptance of AgBiotech products by the general public, farming communities, policymakers, and the media. To achieve this, AfricaBio hosted a Business Breakfast on the status of the drought-tolerant maize varieties that will be deployed to small-holder farmers in SA. We also hosted a regulators', scientists' and farmers' round-table discussion in Zambia on BT cotton.
BIOTECHNOLOGY AND BIOSAFETY STUDY TOUR TO SOUTH AFRICA FOR KENYAN REGULATORS, FARMERS, AND SEED TRADERS
AfricaBio, in collaboration with the AATF and ISAAA, co-organised a "seeing-is-believing" tour for Kenyan farmers, regulators, journalists, cereal-milling associations, and seed traders to visit small-holder farmers planting biotech crops. The objective of the study tour was to create a platform for information-sharing between the Kenyans and their South African counterparts. The delegation had an opportunity to gain first-hand experience about the regulation and cultivation of biotech crops in South Africa. The study tour included presentations and discussions with South African regulators, technology developers, biotech and biosafety experts, as well as field visits to GM fields. Participants had the opportunity to visit farms cultivating biotech maize, soya, and cotton. South Africa has the longest history of planting biotech crops in Africa and is the leading country cultivating biotech crops on the continent. It is envisaged that the study will help Kenya to learn from the South African experience and develop champions of the technology once the Kenyan ban is lifted.
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.
EMERGING REGULATORY MATTERS
The emerging regulatory issues such as GM product labelling, GM stacked events, low level presence (LLP) and asynchronous approvals, regional trade etc., brings its own set of challenges, as we have seen in South Africa. Thus South Africa's over 18 years' experience in GM crop adoption can and will play an essential and exemplary role for the rest of the continent. New innovative technologies such as oligo-directed mutagenesis, cis- and intragenesis, grafting on GM rootstocks, reverse genetics, zinc finger nucleases, and synthetic genomics and their possible regulatory implications and classification as GMOs which advance and build on conventional breeding technologies, have recently received global attention. These technologies have the potential to meet the characteristics sought in new food products, including better tolerance of biotic and abiotic stress, as well as improved nutritional quality. Debates are already under way in the EU regarding the regulatory requirements for some of these new technologies, and whether some of the new techniques constitute genetic modification, and whether they should be classified as GMOs. The resultant crops produced with some of the new technologies are indistinguishable from their conventionally bred counterparts and therefore, tested against the 1990 GMO definition, cannot be considered GMOs. Meanwhile, in Africa, most countries are basing their biosafety legislation on the definition of a living modified organism (LMO) provided in the Cartagena Protocol on Biosafety. This is another area that will further pose regulatory hurdles if not addressed properly. AfricaBio is already at the forefront in addressing some of the issues described above, and is positioning itself as the go-to organisation to provide advice and expertise for other African countries by:
Providing networks, training, and linkages to international experts and resources to SA regulators
Inviting international experts to workshops with Executive Council on GMOs members
Holding one-on-one meetings with policymakers and regulators
Collaborating and partner with relevant government departments on projects where required
Playing a key role in the implementation of the SA Bio-economy strategy
Facilitating "seeing-is-believing" tours for SA parliamentarians
Assisting regulators to address emerging regulatory issues promptly
Working with relevant stakeholders and role players to address emerging issues
Conducting research/reports or submit recommendations that could inform regulatory decisions
ADVENTITIOUS PRESENCE (AP) OR LOW-LEVEL PRESENCE (LLP)
AP or LLP refer to the unintentional and incidental commingling of trace amounts of one type of seed, grain or food product with another. This includes foreign matter or grain from other traded crops, and it is normally managed by agreeing on quality standards and monitoring. When used in relation to plant biotechnology, the term refers to the incidental presence of biotech-derived material in food, feed, or grain at levels that are consistent with generally accepted agricultural and manufacturing practices. AP is an unavoidable reality of plant biology, seed production, and the distribution of commodity crops.
There are a number of factors that contribute to commingling: pollen flow; volunteerism; mixing during harvesting, transport, storage and processing; human error; and accidents can all play a role in adventitious presence. While adventitious presence can be minimised, as a practical matter it cannot be eliminated entirely and is not unique to crops enhanced through biotechnology. As a result, allowances for adventitious presence have been recognised in laws, regulations, and standards that establish allowances for these materials. Adventitious presence of biotech products does not compromise food safety.
How can it be prevented?
A growing number of countries have established risk-assessment procedures for approving the import of biotech crops and their derivatives. However, many of these countries have not, as yet, adapted processes to address the potential low-level presence in their imports of biotech material already authorised and being produced in other countries, but not yet approved (and therefore not intended to be present) in the importing country. This gap has the potential to cause significant trade disruptions, as well as placing significant burdens on the importing country's authorities when such presence is detected. The situation will only become more prevalent as more and more new biotech plants are developed and enter into commerce at different rates in different countries. Minimising the occurrence of adventitious presence is always preferred over other solutions. AfricaBio and its members, believe that the primary approach to managing adventitious presence in the supply chain must remain:
The implementation of rigorous good agricultural practices (GAP) for the cultivation of biotech crops; and
The implementation of good manufacturing practices (GMP) throughout the agri-food chain for products that are authorised in the country of production but not yet in an importing country.
It is the policy and accepted best practice of the developers of biotech plant varieties to seek authorisations in countries which import significant amounts of the crop in which a biotech plant product has been introduced. The fact that authorisations are granted over different timescales is due to differences in the operation of different countries' regulatory systems.
FOOD AND FEED SAFETY ASSESSMENT
GM FOOD AND FEED SAFETY
Foods and feed derived from GM crops undergo more testing than any other food in history. Before entering the marketplace, they are assessed using guidelines issued by several international scientific agencies such as the World Health Organization, the Food and Agriculture Organization, and the Organization for Economic Cooperation and Development. These guidelines include the following:
• GM food products should be regulated in the same way as foods produced by other methods. The risks associated with foods derived from biotechnology are of the same nature as those for conventional foods.
• These products will be judged on their individual safety, allergenicity, toxicity, and nutrition rather than the methods or techniques used to produce them.
• Any new ingredient added to food through biotechnology will be subject to pre-market approval in the same way a new food additive, such as a preservative or food colour, must be approved before it reaches the marketplace.
GM FOOD AND FEED SAFETY ASSESSMENT
Before any GM food can enter the market, it has to be exhaustively tested by the developer and independently evaluated for safety by scientists or experts in nutrition, toxicology, allergenicity, and other aspects of food science. These food safety assessments are based on guidelines issued by the Department of Health country and include: a description of the food product; detailed information about its proposed use; and molecular, biochemical, toxicological, nutritional, and allergenicity data. Typical questions that must be addressed are:
• Does the GM food have a traditional counterpart that has a history of safe use?
• Has the concentration of any naturally occurring toxins or allergens in the food changed?
• Have the levels of key nutrients changed?
• Do new substances in the GM food have a history of safe use?
• Has the food's digestibility been affected?
• Has the food been produced using accepted, established procedures?
• Even after these and other questions about the GM food are answered, there are still more steps in the approval process before the GM food can be commercialized. In fact, GM foods are the most studied food products ever produced
Substantial Equivalence (SE) in Safety Assessment of GM Foods
Absolute safety is unattainable for any food as people react differently to natural ingredients of food. Substantial equivalence (SE) is an alternative approach used for the safety assessment of genetically modified foods where traditional toxicological testing and risk assessment to whole foods could not be applied. It is based on the idea that existing products used as foods or food sources can serve as basis for comparison. The safety assessment is therefore based on a comparison of the modified food to its traditional (non GM) counterpart in terms of molecular, compositional, toxicological and nutritional data. SE has been used in the safety assessment of GM crops available today.
ENVIRONMENTAL RISK ASSESSMENT
The debate over the environmental impact of genetically modified (GM) crops has escalated in complexity and intensity regarding its impact on the environment. As new research is published, it becomes more complicated. Assessing the environmental impact of GM crops is difficult as there are many factors that need to be considered. Some scientists focus on the potential risks of GM crops, while others emphasise their potential benefits.
What are the risks and how can we address them?
GM crops are thoroughly evaluated before entering the marketplace. Many stakeholders assess them in line with a set of principles that were agreed on by environmental experts across the globe. Further, an increasing human population is responsible for wilderness destruction, water-quality problems, and diversion of water. Loss of habitat has resulted in many species being displaced. Thus, to conserve forests, habitats, and biodiversity, it is necessary to ensure that future food requirements come only from cropland currently in use. Among those who conduct risk-assessment procedures are the developers of GM crops, regulatory bodies, and academic scientists. Most countries use similar risk-assessment procedures when considering the interactions between a GM crop and its environment. When assessing GM crops' impact on the environment, the following is considered:
The role of the introduced gene
The effect that it brings into the recipient plant
Impact on non-target organisms in the environment
Will the modified crop persist in the environment longer than usual or invade new habitats?
Likelihood and consequences of a gene being transferred unintentionally from the modified crop to other species
STACKED TRAITS
Seeds with biotechnology traits are now widely planted around the world, and many of those seeds have more than one biotechnology trait. By inserting more than one gene in a seed via biotechnology, farmers now have the means to combat insects and control weeds, using fewer or lower impact insecticides and herbicides. These plants help farmers get more production on each acre being farmed, using less fertiliser, fewer pesticides, and no tillage which greatly reduces soil erosion. Biotechnology traits allow farmers to address old problems, such as insect damage that reduces yield, with new tools. It also means that farmers harvest more per farmed acre in a more sustainable way. Stacking biotechnology traits can address problems such as above-ground pressure and below-ground insect pressure with two or more traits in the same seed.
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.
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