Micro-organisms, Biopesticides: Environmental Fate and Behaviour considerations for pesticide registration in Great Britain and Northern Ireland

When you are applying for pesticide registration in Great Britain and Northern Ireland for products containing micro-organisms you must consider the product evaluation differently to products containing chemical active substances. A biopesticide is a plant protection product (PPP) that is based on a naturally occurring substance; microbial pesticides are a subclass of this group. A micro-organism used as an active substance in plant protection products is specifically defined under regulation 1107/2009 as ‘a microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material.’ Being living material, they differ fundamentally in their nature from chemical pesticides.

Specific data requirements for microbial pesticides are listed in Regulation 283/2013 for active substance (Part B, section 7) and Regulation 284/2013 for plant protection products (Part B, section 9).

Applicants should follow the approach taken at the active substance approval stage, or other risk assessment documents, where these factors have been considered.

Please refer to Environmental Safety Evaluation of Microbial Biocontrol Agents and Biopesticides for additional information on biopesticides.

Evaluations

You should follow the approach used during the active substance approval stage when applying for product authorisation.

If possible use a ‘risk envelope’ to another product, see Risk envelope suitability for pesticide registration in Great Britain and Northern Ireland.

If an evaluation is required, consider the following general points:

If placed into suitable environmental conditions the population of the applied micro-organism could increase over and above the population that is applied. Reference to the active substance approval evaluation should indicate whether this concern has been addressed during approval
As many micro-organisms occur naturally in the environment, they may be present at high background levels relative to the proposed application rate. Consideration of a proposed use relative to levels in the natural environment may have been given during the active substance approval assessment. Refer to this when making your application

Soil exposure

Calculate for soil exposure following standard methodology with some modifications.

Use the standard assumptions of 5 cm depth and density of 1.5 g/cm³
If degradation data is unavailable, assume a maximum total dose in calculations
Use a crop interception of 0 % for the calculations. Or provide justification to support use of alternative crop interception values

Consider exposure following the production of toxins and/or metabolites. Do this by following the approach taken for the approval assessment if appropriate.

For further details on standard soil assessments see Soil assessment for pesticide registration in Great Britain and Northern Ireland.

Surface water spray drift

Calculate surface water spray drift using standard methodology with some modification.

Use spray drift values appropriate to the crop and number of applications being assessed. In situations where a DT₅₀ is not available, use a maximum total dose approach. The maximum total dose approach assesses all applications as a single dose but uses the appropriate multiple application drift percentile.

For further detail on standard spray drift assessments see Spray drift surface water exposure assessments for pesticide registration in Great Britain and Northern Ireland.

Surface water drainflow

Consider if a drainflow assessment is needed and provide justification based on the information considered at active substance approval stage regarding the likely mobility of residues. If it is stated in the approval documentation that the micro-organism has demonstrated no mobility in soil, provide a case stating that no further consideration of exposure of surface water via drainflow is necessary.

Numerical values for the mobility of micro-organisms and associated residues may not be available in the EFSA Conclusion. In cases where mobility of the micro-organism is apparent and where specific parameters are not available, provide a first-tier calculation using worst case assumptions of 0 % crop interception and Koc of 0 mL/g. Further refinements can be justified on a case by case basis as necessary if the first-tier approach results in an unacceptable risk.

Groundwater

Consider if groundwater assessment is needed and provide justification based on the information considered at active substance approval stage regarding the likely mobility of residues.

If information on the mobility of the micro-organism is not available, provide evidence of consideration of groundwater. Any consideration of groundwater exposure, including a case, should also include any toxins or metabolites identified as relevant at active substance approval stage.

Air

Evaporation and volatility of micro-organisms is not expected to be a factor in assessing the fate in air and hence volatilisation from plant surface and soil might be excluded. Follow the approach agreed at the active substance approval stage.