Biosafety Science

Getting the science right is a fundamental challenge when dealing with pioneering research and new technologies.In a world where human knowledge is ever increasing, yet elusive because of the complexities of nature, of the interactions between humanity and nature and of the dynamics of those relationships over time, an exciting and promising world awaits us if we get the science right.The shift from genetic determinism to modern genetics and the ‘fluid genome’ paradigm raises very basic questions and exposes the assumptions that have been used, and continue to be used, to rationalize and promote genetic engineering (GE), gene biotechnology and many emerging forms of nanotechnology.The new genetics acknowledges that genes have a very complex ecology from which they receive layers of biological feedback over every scale of space-time. The new physics do not separate space and time. While the new genetics have yet to move strongly in that same direction and be mainstreamed, the discipline of “gene ecology” is gaining ground.

The new genetics is holistic genetics. This says that changes in ecological conditions can affect an organism, including its genes and genome. Conversely, a foreign gene introduced into an organism through GE may have influences that propagate outwards to affect the ecosystem. At the same time, a stable, balanced and healthy ecosystem is also essential for the health of genes and genomes.There are also safety concerns over the GE process itself, which greatly enhances the scope and probability of horizontal gene transfer and recombination. This is the main way to the creation of viruses and bacteria that cause diseases. Destabilising genes and genomes through GE can thus be hazardous.

From genetically modified crops and pharmaceutical drugs to health genomics, the hazards are often not known. However, where something can cause irreversible harm, it is right and proper for society, and scientists in particular, to seek evidence that it is safe beyond reasonable doubt. Hence the precautionary principle or approach is crucial.

Unfortunately the quest to ensure safety is often faced with obstacles of denial, and even repression, of knowledge of potential and actual hazards. If we do not seek to ask the necessary questions, if science is not allowed to play its role with integrity and responsibility, then GE will lead to considerable ecological harm and human suffering. At the same time, precious resources needed to support all our societies, especially those in the developing and vulnerable parts of the world, will be wasted.

To ensure biosafety, we need to develop science policies that appreciate the centrality of nature, and connect science with society. Identifying gaps in knowledge, supporting research in holistic sciences and putting the precautionary principle into practice are among the key challenges before us.

Urgent Need for Precautionary Regulation of New GE Techniques

Many potential intended and unintended effects are specific to the techniques of new GE and may result in a new quality of risks that demand independent and mandatory risk assessment. […]

The Need for Horizon Scanning and Technology Assessment to Address the Evolving Nature of Genetic Engineering

Examples of new developments in genetic engineering – gene drives, genetically engineered viruses and RNA interference – demonstrate why horizon scanning and technology assessment are urgently needed. […]

How the CBD Can Improve Governance of Synthetic Biology Developments

This report, published by the German Federal Agency for Nature Conservation, aims to enable governments to be prepared for current and future developments in synthetic biology, namely through the process of technology horizon scanning, monitoring and assessment. […]

Transgene Flow into Maize Landraces in Brazil

A study has found that 34% of samples of Brazilian maize landraces contained GM maize proteins, demonstrating the challenge of keeping transgene flow in check. […]

Risky Research Eroding Norms on Release of GM Self-spreading Viruses

This publication warns about the erosion of the general consensus that laboratory modifications of self-spreading viruses are genetically too unstable to be used safely and predictably outside contained facilities, opening the door to risky research. […]

Genome Editing Not a Solution to Climate Change

This new report shows how genome editing will only entrench the destructive patterns of industrial agriculture, making it a false solution to the climate crisis, and why agroecology is the more sustainable solution for agriculture. […]

Large Unintended Structural Changes Induced by CRISPR-CAS9 at Off-Target Sites in Fish

A study using CRISPR/Cas on zebrafish is the first to detect large unintended structural changes at off-target sites. […]

Genome Editing-Induced DNA Repair May Result in Unintended Outcomes

Genome edited organisms must be strictly regulated to allow for thorough characterisation of the full spectrum of unintended effects associated with the technology. […]

A Critical Control Points Framework to Regulate New Genetic Technologies

A proposed framework that regulates new biotechnologies by using a ‘critical control points’ governance framework to regulate technology consistently with its risk to cause harm. […]

Urgency to Assess and Regulate Gene Drives

The world community must take sufficient time to build a consensus on how to deal with gene drives, and on how to assess the ecological, medical, ethical, cultural, scientific and international legal issues involved. […]