The EU could also soon face significant gaps in risk assessment
In a recent publication, scientists warn of the inadequate regulation of genetically engineered microorganisms in the US, as Testbiotech reports. Using three case studies, they highlight significant gaps in risk assessment before market approval. According to their findings, a fragmented approval system with unclear responsibilities and insufficient approval standards causes risks for health and the environment not being adequately assessed.
The three examples involve genetically engineered bacteria that have already been approved in the US. They are intended to capture nitrogen in the soil, aid in tooth brushing, or mitigate the effects of alcohol consumption. Although the companies submitted some dossiers, the authorities did not conduct a sufficient review. According to the publication, risks such as unintended changes to the microbiome, spread into the environment, and human-to-human transmission were omitted.
The scientists make recommendations regarding what a minimum standard for risk assessment and regulation should entail. These standards should take into account whether the microorganisms can persist and multiply in the human microbiome and alter it, whether they can spread unintentionally into the environment, displace natural microorganisms, or whether they can be unintentionally transmitted from person to person. The location and scope of releases should be considered as well.
In the EU, risk assessment standards are currently significantly higher than in the US. However, this regulatory framework could also become fragmented in near future. For many genetically engineered microbes, fast track approvals may be permitted, without any monitoring and time limitation of authorisations. A new Directive could be passed by Parliament as early as November.
One of the products examined by US scientists could benefit from this deregulation. It is based on genetically engineered Bacillus subtilis, a species of bacterium commonly found in the human gut, in soil, and in animals. This bacterium is included on a list of microorganisms classified as safe in the EU.
The product is intended to mitigate the effects of alcohol consumption. According to the manufacturer, the product is free of virulence factors, pathogens, and transmissible antibiotic resistance genes, and therefore does not differ significantly from its natural form. Such criteria are also presented by the European Commission as a basis for future fast track releases and waiving of monitoring measures. However, the US scientists point out that there have been several reports of potential side effects associated with this product and that there is a risk of unintended human-to-human transmission of these genetically engineered organisms.
Against this backdrop, Testbiotech calls on the European Parliament to halt the proposed legislation. Similar demands were also expressed in a joint letter from civil society organisations and the umbrella organisation of European ecologists. In addition, prominent French scientists recently took a similar stance in a joint op-ed published in the newspaper Le Monde.
Further information
The new scientific paper
The civil society letter
Ecological Society of Germany, Austria, and Switzerland (GFÖ) statement
Le Monde op-ed by French scientists
Testbiotech report: “Dark matter microbes – The EU‘s GMO Regulation must prepare for the world of tomorrow”
Source of commentary: Testbiotech
Image: Shutterstock (licensed purchase)
