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.

New GM Plants Must be Subject to Case-specific Premarket Risk Assessment

The products of new GMO techniques, including genome editing, cannot be assumed to be safe but must be subjected to a pre-market risk assessment tailored to the specific GMO in question. […]

Treat Gene Drives with the Utmost Precaution, say Independent Scientists

This report published by three independent scientific organisations concludes that gene drives should be treated with the utmost precaution. […]

International Scientists Urge Precaution with Gene Drives: New Study

Gene drives should be treated with the utmost precaution, international scientists conclude in a new and comprehensive study. Until effective, legally binding international regulation is in place, as well as genuine public engagement, no gene drive organisms should be released, the study recommends. […]

Briefing Paper: Gene Drive Organisms: What Africa Should Know About Actors, Motives and Threats to Biodiversity and Food Systems

This paper explains the serious risks and complexities that gene drive organisms pose to human health, the environment and society, particularly in the African context. […]

Genome Edited Plants Need Stringent Regulation

There are significant differences in methods of production, traits and risks of genome edited plants in comparison to those derived from conventional breeding, necessitating strict regulation of the former. […]

Regulation of Plants Developed by New Genetic Modification Techniques

Existing regulatory frameworks for GMOs cover new GM techniques (nGMs) to varying degrees. Whether nGM applications fall under biosafety frameworks is critical for the scope and the quality of risk assessment. An international public registry listing all biotechnology products commercially used in agriculture is needed for transparency of the regulatory status of individual nGM products. […]

The Implications of Gene Drives on Human Rights

Gene drives will have impacts on ecosystems and human rights. This paper calls for States to observe their obligations in the context of human rights, biodiversity and biosafety, including by putting in place a global moratorium on gene drive releases. […]

Fate of GM food-derived DNA in the Human Body

DNA derived from GM food in the human body can be found in the blood and tissues of humans and animals, and plant-food-miRNAs can survive digestion, enter the body and affect gene expression patterns in different organs. […]

Genetic Engineering Technique Causes Unexpected Genome Damage

A new study shows that the GM transformation process in plants is extraordinarily damaging at a genetic and epigenetic level. […]

The Need for Better Risk Governance of Gene-Edited Products

This paper identifies the challenges posed by new and emerging gene-editing techniques, as well as recommends improvements to GM risk governance research and practice. […]