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As part of the on-going preparation for the upcoming 15th Meeting of the Conference of the Parties (COP15) simultaneously with the 10th Meeting of the Parties to the Cartagena Protocol on Biosafety, the Department of Science and Technology – Biosafety Committee (DOST-BC) invited Dr. Felicity Keiper from the Global Regulatory Affairs – Seeds and Traits, BASF last 21 November 2020 to talk through virtual platform on Synthetic Biology.

 

Dr. Keiper is an Expert in Global Regulatory Affairs in the Seeds & Traits business of BASF. She has worked in agricultural biotechnology for almost twenty (20) years, with twelve (12) years in regulatory affairs. She works predominantly in regulatory policy with focus on developments in international law that impact Research and Development (R&D) activities. 

In her presentation, Dr. Keiper provided an overview about the Convention on Biological Diversity (CBD) and highlighted the three main objectives of the CBD which are:

  1. The conservation of biological diversity
  2. The sustainable use of the components of biological diversity
  3. The fair and equitable sharing of the benefits arising out of the utilization of genetic resources

She also mentioned that the CBD is ratified by 196 countries (“Parties”), which include all countries of the world except for the United States of America (USA). She added that it also provides the legal basis for a supplementary protocol, the CBD’s first subsidiary agreement, the Cartagena Protocol on Biosafety. The Cartagena Protocol sets out a regulatory framework for the safe use, handling and transfer of living modified organisms (LMOs). In addition to the Cartagena Protocol, the CBD has also produced a second subsidiary agreement, the Nagoya Protocol on Access and Benefit Sharing, with the Cartagena Protocol also having a supplementary protocol on the topic of liability and redress. At this point, she stressed the relevance of the CBD to the biotech regulation: that we have an obligation to regulate, and an obligation to define regulatory procedures.

Moving on, she said that under the CBD synthetic biology is an umbrella term encompassing, e.g.:

  • Parts, devices & systems: e.g., minimal cells, “chassis” cells
  • Enabling tools: e.g., genetic engineering, genome editing, DNA sequencing, DNA synthesis, biocomputing, artificial intelligence
  • “New” applications of established biotechnologies: e.g., metabolic engineering, RNAi-based gene silencing
  • New types of applications: e.g., xenobiology, gene drives

And what it is not is herbicide tolerant & insect resistant biotech crops.

Dr. Keiper further discussed that under the CBD, synthetic biology is considered a “New and emerging issues” (NEI) relating to the conservation and sustainable use of biological diversity. While in reference with the CBD/Cartagena Protocol, there is ambiguity on the scope of existing regulatory oversight, whether it covers synthetic biology, and whether synthetic biology covers gene drive and genome editing, thus, taking into consideration the adequacy of existing regulatory oversight in terms of:

  • Risk assessment methodology
  • Risk management procedures, including the availability of detection methods
  • Application of the precautionary approach

And lastly, in consideration of CBD/Nagoya Protocol, Digital Sequence Information (DSI) is an issue that arose from the CBD synthetic biology discussions, and since 2016 has been a substantial stand-alone agenda item under consideration jointly by the CBD and the Nagoya Protocol. Dr. Keiper mentioned that there is divergence of views on:

  • Scope of the CBD “genetic resource” definition
  • Definition and scope of “DSI” (and an appropriate alternative term)
  • The need for and approach to any benefit sharing associated with DSI

It is expected to be a major topic at the upcoming Biodiversity Convention, where it will also be deliberated in the context of the Post-2020 Global Biodiversity Framework.

Finally, Dr. Keiper concluded that synthetic biology is a stand-alone agenda item under the CBD, and it will also be considered within the NEI agenda item in October 2021 where the governing bodies of the CBD (COP15) and its Protocols (COP-MOP10 for the Cartagena Protocol; COP-MOP4 for the Nagoya Protocol) will meet in concurrent sessions in Kunming, China. Deliberations on these two agenda items will be based on draft recommendations which will be produced at SBSTTA24 in May 2021. #