Danièle Court Marques - Microorganisms - Part I: Toxicological Aspects
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  • 1. Committed since 2002 to ensuring that Europe’s food is safe Microorganisms: Current Review Programme -initial comments & key issues; Part I: Toxicological aspects Danièle Court Marques Mammalian Toxicology Team ECPA-IBMA workshop with EFSA – 26 April 2012
  • 2. Identity• For the production process the one issue is the possible production of secondary metabolites of unknown toxicity. Literature searches can be useful but are rarely conclusive• No risk assessment can be made on pathogenic contaminants, it is up to risk managers to agree on acceptable levels of microbial contaminants. OECD issue paper is the most up to date proposal, but its implementation is sometimes unclear• Analytical method specific to strain level. Down to which level of detail should it be conducted? 2
  • 3. Mammalian toxicology• Is extrapolation of toxicological data possible from strain to strain? When, how, based on what? When/how can studies on effects performed with one strain or at subspecies level be extrapolated to other strains?• Relationship between the growth temperature of the microorganism and its pathogenic potential: is the absence of growth at the human body temperature in vitro sufficient to exclude a pathogenic potential of the microorganism? Could some tests be waived if the microorganism does not grow at the temperature of the human body ? 3
  • 4. Mammalian toxicology• Exposure assessment methods: are the usual models used for chemicals applicable to microorganisms? How to assess the exposure of the operators, workers, bystanders/residents ? Should we make use of a natural background level, how could this be determined?• Investigation of the sensitisation potential: there is no appropriate test method to detect skin and respiratory sensitisation to microorganisms. 4
  • 5. Mammalian toxicology• Production of toxins/ secondary metabolites before application (in the technical and during storage) and after application (related to the exposure of re-entry workers and consumers). 5
  • 6. Residues• Are relevant metabolites applied to the crop in the formulation?• Are relevant metabolites formed in the environment that are then taken up by the plants?• Does the organism grow on or in the plant and produce relevant metabolites? 6
  • 7. • Further questions ? Thank you for your attention 7