Csaba Szentes - Micro-organisms: Part II: E-fate and ecotox

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Csaba Szentes - Micro-organisms: Part II: E-fate and ecotox

  1. 1. Committed since 2002 to ensuring that Europe’s food is safe Micro-organisms: Part II: E-fate & Ecotox Current Review Programme – initialcomments & key issues; data requirements & potential data gaps. Csaba Szentes, Laura Padovani
  2. 2. Initial comments & key issuesFrom the data requirements:Experimental data are normally required unless itcan be justified that an assessment of its fate andbehaviour in the environment and an assessmentof effects on non-target organisms can beperformed with the information already available.This justification can be based on open literature,on practical experience and, on informationsubmitted in sections 1 through 6. 2
  3. 3. Initial comments & key issues• Weak dossiers • No data, nor appropriate reasoning • Information from open literature is not summarised in sufficient detail or is not from primary sources• Unclear GAP 3
  4. 4. Data requirements - Fate• Persistence and multiplication (soil, water, air) • Information on viability/population dynamics should be reported in representative soils (or relevant media) • Information should be reported on viability/population dynamics in natural sediment/water systems • information on the concentrations in air might be necessary Estimated levels of the specified m.o. in a time course after use of the product under the proposed conditions of use shall be given• Mobility The possible spread of the m.o. and its degradation products in relevant environmental compartments has to be evaluated 4
  5. 5. Potential data gaps- Fate• Natural background concentrations (in soil)• Data to address the persistence and survivability in water (influence of UV light)• Satisfactory information demonstrating that MO will not persist in the environment and any relevant toxins/secondary metabolites produced by MO will not occur in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years 5
  6. 6. Data requirements – Ecotox.• Birds• AO (fish, invertebrates) Information on toxicity,• Bees infectiveness and pathogenicity must be• NTA reported• Earthworms• Algae Information of effects must• Aquatic plants be reported 6
  7. 7. Data requirements – Ecotox. Impact on relevant non-target micro- organisms and on their predators (e.g. protozoa for bacterial inoculants) should beSMO reported. Expert judgment is required to decide whether additional studies are necessary. See also UP (!) The additional studies might include further acute studies on additional species orAdditional processes (such as sewage systems) orstudies higher tier studies such as chronic, sub- lethal or reproductive studies on selected non-target organisms. 7
  8. 8. Potential data gaps - Ecotox.• Is RA for wild mammals required? See also UP (!)• Is RA for STP required?• Study design • What is the right study duration? • MoA may trigger additional issues • M.o. vs. formulation in aquatic studies• Extrapolation of the results (or assessments) between strains/species• Natural background concentrations vs. exposure• Secondary metabolites present in the product and in relevant environmental compartments 8

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