Danièle Court Marques - Microorganisms - Part I: Toxicological Aspects
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?
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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 ?
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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.
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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).
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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?
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