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#1054 Ecotoxicology of MPCA

Objective of the study

The nature of microorganisms and the specificity of their relationship to their hosts which is usually highly specific, means that based on the taxonomy, biology and ecology of a Microbial Pest Control Active (MCPA), minimal non-target species information is likely to be required.

If from the environmental fate work, there is no significant additional exposure in either soil, water or air, then ecotoxicological information may not need to be provided.

Circumstances under which the study is recommended to be required

For insect pathogenic MPCAs, consideration may be given to whether there may be an effect on bees.

It is recommended that for non-indigenous MPCAs and for indigenous MPCAs which are used in different ecological compartments than those where they naturally occur, information which is provided can be useful to answer the questions on possible ecotoxicological effects.

Principles about reasoned cases for non-provision of studies

For some species and strains of MPCAs there may be significant amounts of good quality literature on related strains or species or in-house studies such as specificity to host or decline of populations in the environment that can be provided to justify non-provision of study data.

If, based on the nature of the microorganism and confirming that there is potential for environmental exposure, it is not possible to exclude non-target species concerns, then for either the microorganism and/or the relevant secondary compounds (metabolites) it can be useful to consider if they are likely to be present at levels below those documented in the relevant environmental compartment. If they are, then a reasoned case can be made to justify why they will not represent a significant non-target organism risk.

If the MPCA is not active, meaning it does not grow or multiply, at temperatures which match the internal temperatures of birds, then a reasoned case for not supplying an avian study could be considered.

For fish testing, if the ecological niche of the MPCA is not suited to aquatic environments in that it does not persist in water, then a reasoned case may be made for not supplying a fish toxicity study.

Test organism or substrate

The entire MPCA.

Typical information to be provided by the applicant

Information obtained from good quality literature will be provided on the microorganism itself and any secondary compounds (metabolites).

Information provided for ecotoxicology usefully includes details about:

  1. Avian toxicity
  2. Fish toxicity
  3. Effects on bees

Ref. 1:     Information on whether the MPCA would be toxic to birds depends on the biological nature of the MPCA. Most microorganisms used in plant protection would not persist at temperatures which occur inside birds. Also, information from the environmental fate section can be used to show that the risk of a bird picking up the MPCA in levels high enough to be toxic, should the MPCA produce relevant metabolites, could be insignificant.

Ref. 2:     Information on the biological properties of the MPCA are usefully added in this section. MPCA from strains of microorganisms which are not suited to aquatic environments would show low risk of toxicity to fish and other aquatic organisms.

Ref. 3:     MPCA which are insect pathogenic may show toxicity to bees. Information on the biological properties from Section 2.0 would usefully be presented here to determine if the risk is great enough to provide a bee toxicity study.

Typical endpoints of the study

Typically, end points for ecotoxicological studies will be the amount of cfu/kg body weight for an effect to be observed. Often, no significant adverse effects are observed even at the highest rate, leaving the official end point to be represented above the tested dose or concentration, according to the test method used.

Testing guidelines

There is no single guideline appropriate for use for MPCA. The applicant will use either one of the guidelines below or a combination, with adjustments suited for the test product. The information will also be from good quality literature and experimental reports. Due to the commitment to reduce vertebrate testing, it is encouraged to allow alternative test methods if valid.