News
Grassroots
August 2017
Vol. 17, No.3
18
workshop on the regulatory implications of new breeding techniques and their relevance to the South African
biotechnology sector was held in Pretoria on 20 June 2017.
The workshop followed a consensus study recently released by the Academy of Science of South Africa (ASSAf). This consensus study, Regulatory Implications of New Breeding Techniques, was undertaken on behalf of the Department of Science and Technology (DST), and aimed to investigate the biosafety implications of new genetic engineering technologies and the robustness of current biosafety regulations to accommodate the new technologies. This consensus study examined the possible regulatory implications of “New breeding techniques” (NBTs) within the South African context by considering the following:
- The relevance of NBTs to the South African biotechnology sector.
- The possible biosafety implications of NBTs.
- The possible fit (or differentiated fit) of these techniques and/or their products with existing GMO legislation.
- The robustness of the current biosafety risk analysis frameworks to accommodate these and possible future techniques and their products.
- The need for the GMO Act and its regulations to adapt in order to accommodate current and possible future genome modifying technologies.
The most critical findings of this study were:
- NBTs is a non-specific collective name for a wide and evolving range of techniques aimed at modifying genomes and/or gene expression, which have great potential as they allow the relatively quick, efficient, accurate and cost-effective modification of valuable genetic traits in crops, livestock and industrial microbes. These include gene editing techniques, null segregants, variations on genetic modification and transgrafting.
- Internationally, only Argentina has published an official, national framework on how to regulate the products of these techniques. In addition, in countries such as Canada, which has a strong product-base regulatory trigger, there is no need to make technique/process-based amendments. It is evident that the great majority of authors and organisations, who have considered this issue, consider the principle of case-by- case decision-making as an important component of any framework.
- When dealing with any type of genome modification, the principal source of risk, i.e. hazard, is the organism whose genome has been changed, i.e. the product, and not
the process or techniques through which these changes were induced. This resulting
product should therefore be the trigger and subject of regulation, i.e. risk management
practices, and the regulatory requirements should be proportional to the possible risks
it poses.
South Africa has a robust and experienced regulatory system for GMOs, which can
without much change be applied to also effectively regulate the products of these new
techniques and, in fact, any genome modifying techniques that may still be developed
in the future. The key for allowing this is that the GMO Act (Act15 of 1997), as it
stands,
has a product-based trigger
sets genetic variation beyond that which may also occur naturally as the threshold
for regulation.
The report is available on www.assaf.org.za.
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Regulatory implications of breeding techniques examined
Admin
Academy of Science of South Africa (ASSAf)
http://www.assaf.co.za/newsletter/?p=1696
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