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
What is it"?
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.
Why does it happen?
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.
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
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.