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Health risks

Based on the available information, no clear immediate hazard could be identified. A qualification to this conclusion is that only a few producers decided to reveal the identity of their microbes to the project team. As a general pattern, risk-relevant information obtained from producers was fragmentary and lacking in technical detail.

As highlighted in the preceding section, some aspects deserve more attention, and presumably, regulatory oversight:

  • • the precise taxonomic identification of the microbes used as the basis of the entire risk assessment should be conducted according to OECD guidance
  • • the process control and quality assurance systems in place to avoid having unwanted microbes should be reviewed/included in the regulatory oversight
  • • the relevance of the risks associated with chronic exposure to dusts and aerosols containing vegetative cells and spores should be clarified
  • • the risks linked to the use of strains which belong to species known to include opportunistic pathogens and possible hazards for particular risk groups (e.g. YOPI) should be clarified; this is linked to possible restrictions in, e.g. hospitals, retirement homes, child care
  • • the risks associated with particular species, some strains of which are known from cases of food contamination and poisoning; should be clarified. This is linked to possible restrictions of the application in areas where food is being handled and processed.

Taking into consideration the different practices of producers in terms of risk assessment and quality assurance, a risk assessment protocol should be developed which also includes the requirements for taxonomic identification. In the course of establishing this protocol, the above issues could be clarified - even if uncertainties prevail - and the consequences for risk assessment and risk mitigation measures could be agreed upon. An internationally harmonised approach would thereby be in the interest of producers and users. Such an initiative, advocated by Canadian, Dutch and US authorities, could therefore be launched at the EU or international level, for instance at the OECD. A good starting point would be the existant guidance documents established for risk assessment in the context of the Canadian New Substance Notification and for the product review in the course of the US EPA DfE programme. Until these issues are properly addressed/clarified, a clear-cut recommendation in favour of using microbial cleaners as spray in closed environments or for cleaning carpets and upholstery cannot be provided.

Given the results of the VWA study and as long as there is no regulatory oversight, the occurrence of possible harmful contaminants should be checked by a third party. This could be done by conducting a microbial analysis of a microbial cleaner, e.g. at the beginning and the end of its shelf life. Very similar to the analysis of the VWA - which was conducted some ten years ago - such a study could verify the identity and quantity of the microbes intended to be present and identify possible (harmful) contaminants.

 
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