Proposals for bacterial and fungal biocontrol agents

Abstract

Registration of biological control agents containing micro-organisms is a long-lasting and costly procedure and has discouraged companies investing in the development of microbial biological control products. Risk assessment and regulation of microbial biological plant protection products is reviewed to develop proposals for an improvement of the current system. Minimum data requirements to be presented during pre-submission meeting were defined in order to support decisions on data requirements for the dossier and possible waivers. Criteria for the possible inclusion of microbial biocontrol agents into the low risk products list and support for the discussion of a comparative risk analysis are discussed. Major problems are the lack of validated risk assessment methods for microbials, knowledge gaps on the natural distribution of the biocontrol micro-organisms and on natural exposure of humans and other non-target organisms, and missing definitions allowing the identification of low risk products. Potential alternative approaches for the assessment of infectivity, toxicity, identification of relevant metabolites and the risk assessment procedures for metabolites and sensitisation are discussed. Proposals for waivers for potentially obsolete data requirements related to infectivity, effect on soil biota, fate and behaviour in the environment and genetic stability are recommended. © 2011 Springer Science+Business Media B.V.