#1301 Biological Properties of MPCA/Active Substance

Objective of the study

Microorganisms are specialist types of plant protection and public health substances that require specialist know-how. Details about the microorganism’s biological properties is the foundation of any application made and are therefore recommended to be provided in sufficient detail to describe well the biology and ecology of the MPCA.

Most of the MPCA submitted for approval will be viable microorganisms but even when they are non-viable, the aim is to provide sufficient information for the evaluator to gain a good understanding of the biology and ecology of the microorganism. In addition to the microbial cells, microorganisms have the potential to produce secondary compounds (metabolites) so this information will also be provided.

This section of the application is usually the most extensive and detailed and it is expected that it will be cross-referenced for every other section of the dossier.

Circumstances under which the study is recommended to be required

The biological properties of the MPCA are always required.

Principles about reasoned cases for non-provision of studies

This requirement cannot be waived. However, there are no specific studies so information from good quality literature can be provided on the MPCA’s biology and ecology. Plus, relevant in-house studies conducted during research on the microorganism or the MPCA.

Test organism or substrate

The entire MPCA.

Typical information to be provided by the applicant

Information obtained from good quality literature can be provided on the microorganism itself and any secondary compounds (metabolites). It may also include one or more good quality study reports that are done by the applicant or by a suitable research facility with expertise in the microbial species.

Experimental results may be provided on different aspects of the MPCA biology for example (but not limited to) the strains, temperature growth profile, ability to infect a range of hosts, survivability on plants. If experimental reports are provided, they are best when they are of good quality for example, contain details of the experimental aims, methods, results and conclusions. The conclusions will be a good summary of the experiment’s findings.

Information provided for biological properties usefully includes details about:

Origin of the isolate and its method of isolation and the preservation and maintenance of strain during its development.
Historical information on testing and use of the strain; history of use of closely related strains or species; whether the species is indigenous.
Natural occurrence of the microorganism including geographic distribution, hosts, habitat, ecological niche, level of natural occurrence.
Life cycle of the microorganism and information regarding closely related species.
Information on target organism(s), including mode of action and available information on host specificity.
Effect of environmental parameters on the microorganism’s growth, dispersal and colonisation ability.
Potential of the microorganism to produce secondary compounds (metabolites) that are of concern for human health and/or the environment and if there are, then information on their mode of action and any toxins and/or degradation products. These may be present in the MPCA and/or they can be produced in situ.
- These secondary compounds (metabolites) may, or may not, contribute to the activity of the MPCA.
- These secondary compounds (metabolites) may, or may not, be of toxicological concern.
Description of any plasmids or other extra chromosomal genetic elements involved in its activity.
Genetic stability (mutation rate of traits related to the mode of action).
Information on whether the microorganisms will produce antibiotics that will interfere with human and veterinary medicines

Typical endpoints of the study

There are no end points for the biological properties.

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, but more commonly the information will be from good quality scientific literature plus some experiment reports.