Objective of the study

Residue information generally needs to be considered when products are to be used in situations which could result in a residue in food or animal feed. Data on the nature and magnitude of residues in crops includes consideration of exposure to the MPCA and any secondary metabolites that are present in the product and remain on the crop after application.

Circumstances under which the study is recommended to be required

This study is not generally required, however good quality information should be presented.

Principles about reasoned cases for non-provision of studies

Information provided on toxicological and exposure data can be used to provide information supporting non-provision of studies for a microbial MPCA. The amount of MPCA which is added to the environment for plant protection purposes does not significantly add to the natural background levels of microorganisms. In addition, microorganisms approved for use in plant protection and public health are not human pathogens, leading to a lack of mammalian toxicity, and so there is neither pathogenicity nor toxicity nor additional exposure, so specific residue studies are not required.

Test organism or substrate

The entire MPCA.

Typical information to be provided by the applicant

1. Rationale for non-provision of studies of specific residue data based on information showing that MPCA is not hazardous to mammals.
2. Rationale for non-provision of specific residue studies based on information that the MPCA is unlikely to occur on treated food/feed stuffs in amounts considerably higher than under natural conditions.

Ref. 1: If there are secondary compounds (metabolites) of established toxicologic concern and/or they are the principal mode of action, then information on likely exposure scenarios to these secondary compounds (metabolites) should be provided and residue studies may be needed.

Typical endpoints of the study

There are no end points for metabolism and residues studies.

Testing guidelines

There are no guidelines specific to microbials, but the following article can be used to understand the rationales often used.

• Scheepmaker, J.W.A. and Butt, T.M. (2010) Natural and Released Inoculum Levels of Entomopathogenic Fungal Biocontrol Agents in Soil in Relation to Risk Assessment and in Accordance with EU Regulations. Biocontrol Science and Technology, 20, 503-552.