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.

Gene Drive Organisms: Implications for the Environment and Nature Conservation

A report endorsed by eight European environmental agencies has been published on the implications on the environment and nature conservation of gene drive organisms. […]

FDA’s Analysis of Genome-Edited Cattle Show Unintended Alterations, Regulation Needed

US FDA scientists report that the gene editing process to produce hornless cattle resulted in unintended alterations at a genome-edited target site, and say this is a reason why regulatory oversight of intentional genomic alterations in animals is needed. […]

Study Finds CRISPR Gene-Editing Fails to Fully Knock Out Genes

A study has found that CRISPR-Cas9 edits intended to knock out the function of a gene fail to do so. Functional proteins are still produced from the damaged genes, which can result in the production of gene-edited plants that are toxic or allergenic. […]

European Parliament Passes Resolution including Call for Global Gene Drive Moratorium

The European Parliament has passed a resolution calling on the European Commission and Member States to call for a global moratorium on gene drive releases into nature, including field trials. […]

Prime Editing Does Not Solve the Problem of Unintended Effects

A new complex technique called ‘prime editing’ is touted to be far more precise than the CRISPR gene-editing tool, but in all likelihood, the same undesirable off-target and on-target effects will occur. […]

Serious Lack of Regulatory Oversight Over Releases of Nucleic Acids and Proteins into the Environment

New technologies allow nucleic acids and proteins to be delivered to cells, tissues and organisms in the open environment. However, the current lack of regulatory oversight could lead to either dual use appropriation or unintended harm to human health or the environment. […]

Right of Communities to Say “No” to Gene Drives

There is urgent need to democratise the development of new genetic technologies such as gene drives, and to continue to demand that proponents of experimental releases are obliged to obtain free, prior and informed consent. […]

Antibiotic-resistant Genes in GM Crops Persist in Wastewater 

Antibiotic-resistant genes that have been inserted into GM crops, which are then consumed as food, are more persistent than previously thought; they are able to withstand wastewater treatment and are taken up by bacteria in the sludge. […]

Serious Threats Posed by Gene Drives for Conservation

Gene drives proposed for conservation purposes pose serious threats because their implementation could have far-reaching unintended consequences and could trigger irremediable modification of the natural environment. […]

Legal and Regulatory Issues Relevant to Gene Drive Organisms

There is an urgent need for effective international and legally binding regulation of gene drive organisms (GDOs). […]