Strengthening capacity – In the fourth installment of the monthly seminar held last 17 October 2020, the Department of Science and Technology-Biosafety Committee (DOST-BC) invited Dr. Brinda Dass, of the Gene Convene – Foundation for the National Institutes of Health (FNIH) to talk about the Risk Assessment of Living Modified Organisms containing Engineered Gene Drives (EGD) via Zoom platform.



The monthly presentations of topics and issues on modern biotechnology such as this, plays a vital role in support of the DOST-BC’s horizon scanning and capacity building initiatives. Horizon scanning helps in assessing whether one is adequately prepared for future changes or threats. If performed consistently and effectively, horizon scanning, when combined with other forecasting tools, can assist in policy making by identifying important needs or gaps.

Dr. Dass is the Scientific Program Manager – Policy Lead in the Gene Drive Research team at FNIH, working to assist scientific and regulatory capacity building in African countries in determining the feasibility of using genetically modified and/or gene drive mosquitoes for malaria control or elimination within their independent regulatory framework.  She gained her expertise at the US Food and Drug Administration, working as a master reviewer on the review, approval, and regulation of genetically engineered animals especially investigational GM insect products (bees and mosquitoes).

Dr. Dass’s presentation covered the following:

  • What is gene drive
  • How gene drives work: population modification and population suppression
  • Gene drive use in malaria control
  • Risk assessment as per Cartagena Protocol on Biosafety (CPB)
  • AHTEG discussion on Risk Assessment of the Terms of Reference, Living Modified Fish (LMF) and Living Modified Organisms (LMOs) containing Engineered Gene Drives (EGD)
  • Next steps on COP MOP 

Dr. Dass mentioned that there are gaps in the existing guidance and priorities on Risk Assessment (RA) as a result of the 2017 submission in response to decision CP-VIII/12 (SBSTTA-22, July 2018). Two priority topics were identified that need additional risk assessment guidance, namely:

  1. Risk assessment of organisms developed through synthetic biology containing EGDs
    • rapidly change the genetics of entire populations
    • difficult to control or remove from environment
    • affect beyond national boundaries

  1. Risk assessment of LM Fish-
  • highly mobile,
  • long life span,
  • can affect wild populations,
  • cumulative long-term effects.


She reported that an Ad Hoc technical Expert Group (AHTEG) was formed for EGD and LM fish to:

  • review the studies conducted
  • consider the need for further guidance to be developed on risk assessment
  • make recommendations, and
  • prepare reports for consideration by SBSTTA

Further on her report, she stated that the AHTEG on EGD agreed that existing RA methodologies would apply but there are some concerns on:

  • lack of prior use history;
  • lack of data;
  • monitoring methods;
  • validated modeling tools; and
  • capacity

With regard LM fish, she said that the AHTEG agreed that existing RA methodologies would apply for LMF but presented some challenges which the existing risk assessment procedure may not be able to address such as:

  • lack of data or methods to collect data to inform the risk assessment process;
  • limited applicability of some risk assessment methodologies to living modified fish;
  • lack of tools to estimate consequences, likelihoods and uncertainty; and
  • difficulties in establishing comparator baselines

In conclusion, Dr. Dass reported that the Convention on Biological Diversity (CBD) Secretariat will prepare a report that will be discussed at the next Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA24) which will determine the particular information to be taken up by Parties at COP15 MOP10 in China in 2021. #