Microbial Pest Control Active (MPCA) and Microbial Pest Control Product (MPCP) used for plant protection and public health are specialist substances and by their nature different to conventional chemical pesticides. They are substances which require specific microbial know-how as well as adapted data requirements and assessment. If the regional or national pesticide registration authority does not have personnel who possess this know-how, it may be necessary to provide training in microorganisms to allow the personnel to evaluate them properly.

For microbial data requirements and assessment, it is recommended to pay attention to aspects that are specific to these specialist microbial biological pest control agents. The factors below are useful to be considered:

1. In some countries, regulatory authorities may be responsible not only for registration but also for approving the safety of a MPCA and MPCP production facility and for ensuring that distributors and users of the products comply with labels. Therefore, it may be necessary to train regulatory personnel to allow them to carry out all these functions.
   
   
2. MPCAs by their nature are different to conventional chemical pesticides so many testing methods will need adaptation. It is important that evaluators who examine the information and data on MPCAs and MPCPs, consider both the test results and the test guidelines followed. Existing test guidelines for chemical pesticides may not be directly applicable to MPCAs and MPCPs, so modified guidelines are usually needed. Some test guidelines or guidance on the evaluation of microbials for pest control, have been developed by the US EPA, the OECD and the EU, and these are referred to in the Toolkit as appropriate.
   
   
3. Information provided by applicants for registration of MPCAs and MPCPs can commonly come from different sources including good quality scientific literature, in-house studies by biopesticide companies, and/or GLP studies for the particular species or strain.
   
   
4. For many microorganisms, the production process from inoculation with the starter material to formulated product may be entirely enclosed and it is therefore not possible to have samples of the active substance (MPCA). In these circumstances it is acceptable for testing to be done with the product (MPCP) only.
   
   
5. In addition to the microbial cells, microorganisms have the potential to produce secondary compounds (also may be called secondary metabolites). These:
   
   
   1. may be present in the product and/or can be produced in situ;
   2. may or may not contribute to the activity of the MPCA; and
   3. may or may not be of toxicological concern.
      
      
6. Secondary compounds (metabolites) need be addressed in the dossier only when they are expected, from literature or studies, to be of toxicological concern, when there would be human or environmental exposure, and/or when they are the principle mode(s) of action.
   
   
7. In practice, microorganisms are usually well identified, which enables regulatory authorities to predict their properties and behaviour. This is particularly true for human and animal health and plant pathogenicity. However, if the MPCA under consideration is taxonomically similar to a clinically or agriculturally-significant microorganism, its properties and effects would need to be examined in detail.
   
   
8. For the more general parts of the dossier, when high similarity within a species has been demonstrated, data for different strains of the same species can be used.
   
   
9. As many of the commonly used microbial species have already been evaluated in other countries, these already-completed assessments can be a useful source of information on the approach used and decisions taken.
   
   
10. Some common microbial species have been used for many years for plant protection or in public health without unacceptable adverse effects, and no such effects are expected, given their nature. Therefore, for certain MPCAs and MPCPs, national evaluators can accept a reduced set of data requirements and take a simplified approach.