TESTBIOTECH Background 08 – 04 – 2024

Summary
The draft opinion issued by EFSA (2024) correctly identifies several deficiencies in current guidance for the risk assessment of genetically engineered (GE) microorganisms. New genomic techniques (NGTs, new genetic engineering) and synthetic biology will enable companies to develop a broad range of GE microorganisms. Therefore, the existing EFSA guidances should undergo an in-depth evaluation in regard to its ability to meet upcoming challenges.
The EFSA (2024) draft opinion only deals with one specific sector, i. e. products currently being developed for use in agriculture and food production. Therefore, further opinions will be needed, e.g. for applications other than for agriculture and food production such as with non-domesticated species or GE microorganisms intended to change the composition of the microbiome in mammals for purposes other than food and feed, as these may also potentially impact food safety.
Furthermore, it does not include important applications within the food production sector, e.g. microbial pesticides, paratransgenesis and application of viruses or synthetic communities of microbes.
Further consideration is also needed in regard to contamination with GE microorganisms (or specific nucleotides) not meant for food production. It should be noticed that Fraiture et al. (2024) found intact antibiotic resistance genes in almost 48% of the enzyme preparations they tested. Since these genes can be transferred to pathogens or microorganisms in the intestinal microbiome, contamination with DNA from GMMs should fall under the GMO Regulation 1829/2003 and should be taken into account by the final opinion of EFSA.
Other considerations in this respect include the concept of the holobiont, the impact of artificial intelligence (AI), the assessment of cumulative effects or interactions and the introduction of cut-off criteria needed in cases where there are too many uncertainties or unknowns.
In addition, it is important to integrate a requirement for data on the phenotypic characteristics of GE microorganisms at each step of risk assessment.
It should be made clear that all microorganisms derived from EGTs or NGTs must be subjected to mandatory risk assessment, as required by current regulation. These microorganisms should be defined as genetically engineered (GE). There does not appear to be any necessity to change current regulatory framework in order to deal with these microorganisms, as the processes used to generate GE microorganisms may be associated with intended or unintended effects unlikely to occur with conventional mutagenesis or similar.
In addition, other microorganisms derived from non-regulated techniques, which have traits or specific characteristics not previously present in the ecosystems / food production, should also undergo mandatory risk assessment. An additional register and decision-making process should be established for this purpose.
Furthermore, risk management recommendations should include measures and methodologies allowing the overall control of the scale of releases into a given receiving environment. This should further include measures to reduce the number and scale of releases.