TWN Biotechnology & Biosafety Series 21 Driving Harm, Reversing Precaution? An Analysis of the Additional Voluntary Guidance Materials on Risk Assessment of LMOs Containing Engineered Gene Drives By Eva Sirinathsinghji Publisher: TWN Year: 2026   No. of pages: 34 Download the book

About the Book

Living modified organisms containing engineered gene drives (EGD-LMOs) are designed to spread genetic modifications through wild populations and persist – a novel technology that brings with it fresh biosafety challenges. In light of these concerns, a set of guidance materials to support risk assessment of EGD-LMOs has been drawn up by a group of experts and welcomed by Parties to the Cartagena Protocol on Biosafety.

However, the guidance materials advocate a narrow approach under which only what are identified as “plausible pathways to harm” are selected for assessment. This methodology fails to sufficiently address the central risks of gene drives arising from their very design objective – spread and persistence.

Instead of being limited in scope, risk assessment should cast the net widely to capture all potential harms of EGD-LMOs. Only then will it align with the precautionary principle that is enshrined in the Cartagena Protocol and that will ensure adequate protection from the possible adverse effects of this controversial technology on biodiversity and human health.

About the Author

Dr Eva Sirinathsinghji has a Ph.D. in Neurogenetics and is a biosafety researcher with a background in biomedical sciences. She works with civil society on the biosafety considerations of genetic engineering technologies. She has served as a member of several Ad Hoc Technical Expert Groups on Risk Assessment and Risk Management established under the Cartagena Protocol on Biosafety, and as a previous member of the Ad Hoc Technical Expert Group on Synthetic Biology established under the Convention on Biological Diversity.

Contents

Chapter 1.	Introduction
Chapter 2.	Discussions on Risk Assessment of EGD-LMOs Under the CBD and Cartagena Protocol on Biosafety
Chapter 3.	The “Pathways to Harm” Approach and Its Industry Links
Chapter 4.	How the “Pathways to Harm” Approach Reverses Precaution “Pathways to harm” select what risks to identify or ignore Selective characterisation narrows risk assessment considerations Reduction in number of pathways deemed “plausible” for testing Proof of harm, rather than identifying risk Focus on intended changes and behaviours downplays unintended changes Reduced need for laboratory empirical testing
Chapter 5.	Central Risks of Gene Drives Remain Unaddressed Ecosystem-wide effects Spread and persistence Gene flow
Chapter 6.	Remaining Gaps and Shortfalls in the Guidance Materials Lack of consensus amongst experts Failure to adequately provide guidance on addressing uncertainties An industry-favoured approach
Chapter 7.	Conclusions
References