1. Committed since 2002
to ensuring that Europe’s food is safe
Micro-organisms:
Part II: E-fate & Ecotox
Current Review Programme – initial
comments & key issues; data requirements
& potential data gaps.
Csaba Szentes, Laura Padovani

2. Initial comments & key issues
From the data requirements:
Experimental data are normally required unless it
can be justified that an assessment of its fate and
behaviour in the environment and an assessment
of effects on non-target organisms can be
performed with the information already available.
This justification can be based on open literature,
on practical experience and, on information
submitted in sections 1 through 6.
2

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. 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. 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. 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. Data requirements – Ecotox.
Impact on relevant non-target micro-
organisms and on their predators (e.g.
protozoa for bacterial inoculants) should be
SMO 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 or
Additional processes (such as sewage systems) or
studies higher tier studies such as chronic, sub-
lethal or reproductive studies on selected
non-target organisms.
7

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