Objective of the study

To be able to evaluate microorganisms, their correct identification and taxonomic status is vital. The aim of this study is that the Microbial Pest Control Active (MPCA) is identified correctly using the best available molecular taxonomic techniques and the specific strain to be registered is compared to the type species and/or other strains of the same species using a good quality (large) taxonomic library.

Circumstances under which the information is recommended to be required

Always required.

Principles about reasoned cases for non-provision of studies

This requirement cannot be waived.

Test organism or substrate

Microorganism contained in the MPCA.

Typical information to be provided by the applicant

The dossier will contain details of a study used for the molecular identification of the microbial strain, referencing the work of the researchers who originally or most recently correctly identified the species. The results will be presented as a phylogenetic analysis, showing the location of the applicants strain relative to other strains of the same and/or similar species. The study does not have to be conducted according to GLP.

A phylogenetic analysis sequences common genetic markers to categorize the organism as a specific species and in addition, to separate out the applicants MPCA from other species present in the publicly curated databases available. The report may take the style of an academic paper; a phylogenetic tree (Figure 1) is commonly how the information is depicted. As taxonomic changes do happen, the more recently the analysis has been run against the public databases, the more accurate it will be.

• For bacteria, the 16S rRNA gene is commonly used, plus others as needed to identify to strain level.
• For fungi and yeasts, the 18S rRNA gene and/or ITS regions is usually sufficient.
• Viruses are classified based on morphology, chemical composition, and mode of replication. Even though viruses differ based on classification, all viruses are similar in structure and contain nucleic acid (genome made up of DNA or RNA) enclosed in a protein coat (capsid).

Figure 1. A phylogenetic tree showing the genetic relationships of various Bacillus species from Wang, A. & Ash, G.J. 2015. Whole genome phylogeny of Bacillus by feature frequency profiles (FFP). Scientific Reports 5 13644. https://doi.org/10.1038/srep13644.


To describe phylogeny, the other study which may be presented is a whole genome sequence (WGS). This is not a data requirement but the study can be useful to provide data for other sections which may be required.

A paper record will be provided that confirms the strain has been placed in an internationally recognized culture collection indicating the strains accession number.

A statement will be made to confirm the strain is not a mutant or genetically modified strain.

A statement will be provided confirming if the strain is indigenous or not and may cross-reference to Data requirement about Biological Properties of MPCA/Active Substance.

Typical endpoints of the study

There are no endpoints, the applicant will provide a paper or study done either in-house or by an expert which correctly identifies the microorganism in the MPCA.

Testing guidelines

There are no guidelines available for this data requirement.