Registration authorities may want to consider including specific provisions for biological pest control agents in existing legislation regulating chemical pesticides or developing separate and specific legislation or regulation for biological pest control agents. Harmonisation of approaches is important for streamlining and facilitating the research, development, commercialisation and use of biological pest control agents for plant protection and public health.

Having similar data requirements and evaluations between authorities should make it easier for applicants to submit applications to different countries and for regulatory agencies to benefit from each other’s reviews.

A number of factors that are unique to biological pest control agents should be considered in their evaluation and registration. This will help to eliminate unnecessary barriers to registration while ensuring a high level of health and environmental protection. The factors to consider are as follows:

• Many of the active substances used in biological pest control agents are well known and studied, so information about them is readily available. As a result, large parts of a dossier may consist of information from published literature and in-house studies conducted by the producer. Such information can be useful and, if it is of good quality and is consistent with current thinking and methodology, can be evaluated in the same way as other information. Evaluators should be aware that names of microbial species may change for taxonomic reasons.
  
  
• Waivers for the submission of certain data, if justified, can reasonably be granted to support the non-provision of certain data. In the registration of biological pest control agents, waivers are most frequently requested for data on residues, environmental fate and ecotoxicology.
  
  
• Exchangeability of data is acceptable in certain cases, for example for certain groups of microorganisms that are known to have common properties.
  
  
• For some biological pest control agents, there may be no distinction between the active substance material and the product. In other words, the active substance and the product are the same material. In such cases, data are only needed on the product.
  
  
• Biological pest control agents are often formulated with materials that are inert or of no toxicological concern. In such cases the active substance will represent the worst-case situation and risk assessment can reasonably be based on the active substance alone.
  
  
• Biological pest control products can be a mixture of different active substances. Where this is the case, it should be clearly indicated during the registration process and on the product label.
  
  
• Suitable or validated testing methods for biological pest control agents are often unavailable, so in-house studies or external expert studies done by independent testing facilities can be used.
  
  
• Countries may not have access to suitable facilities with the resources to work at Good Laboratory Practice (GLP) or Good Experimental Practice (GEP) standard. In this case it may be appropriate to have another justified accredited testing system.

Biological pest control agents can be products that could be subject to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity This is an international agreement which aims to share the benefits arising from the utilization of genetic resources in a fair and equitable way. For countries signed up to this agreement it should be noted that this can apply to many of the biological pest control agents.

The principles and processes of the FAO Guideline for the registration of pesticides, Guidelines on data requirements for the registration of pesticides and the Guidelines for the registration of microbial, botanical and semiochemical substances for both plant protection and public health uses are the framework within which the modules for biological pest control agents in the Toolkit are provided.

The purpose of these modules for biological pest control agents is to provide practical guidance to facilitate best practice in the registration of biological pest control agents for plant protection and public health. It aims to support that evaluations and decisions for registration of biological pest control agents provide an appropriate level of protection of human and animal health and the environment.