Principles for a simplified approach for microbial data requirements and assessment

Many common microbial species have already been evaluated by countries, and these assessments can be a useful source of information on the approach used and decisions taken.

The conditions and criteria for some common species of MPCA/MPCP to be considered for reduced data requirements and a differential assessment are:

1. For the MPCA, provision of information that details the full and unequivocal taxonomic identification to species with strain designation, deposition of the strain in an internationally recognised culture collection, and an accession number.
   
   
2. Sufficient details to confirm the MPCA production process including quality control steps, to clearly demonstrate that the active substance contains no secondary compounds (metabolites) of potential toxicological concern.
   
   
3. Information provided and assessed to confirm that the MPCA is formulated only with non-toxic co-formulants in the product.
   
   
4. Information for the MPCP confirming viability and/or potency of the colony forming units (cfu) as appropriate, following storage.
   
   
5. Sufficient details to confirm the MPCP physical/chemical and technical properties (as relevant for the formulation type).
   
   
6. Information confirming that human pathogen contaminants do not exceed accepted levels in the MPCP.
   
   
7. Sufficient efficacy data provided and assessed to confirm label claims, though extrapolation of uses between crops, for example for the same target pest, is acceptable.

Further details about the conditions justifying specific data waivers or for conducting differential efficacy or risk assessments are provided in the Data Requirements and Assessment Methods modules, respectively.

FAO has published suggestions of fast-track processes for the registration of biological pest control agents to be used for the control of fall armyworm (FAW). {linked when available}