41st Annual Meeting of the Society for Invertebrate Pathology
and 9th International Conference on Bacillus thuringiensis

The value in having Bt products with consistent performance and confirmed safety is an increase in consumer confidence, ultimately leading to increased use and demand of Bt products and potentially other biological control agents. However, poor quality control in even one company can damage the reputation of Bt’s and microbials in general. Assuring biopotency of products by using reliable standards is important, but is only one aspect of QC. At Valent BioSciences, quality control measures are applied at all stages of manufacturing, from strain identity to packaging and distribution of the final product. Recently, Bt products have been appearing in the worldwide market that demonstrate an obvious lack of quality control, even though biopotency may be met. In some cases the products have been misrepresented or adulterated. Thus, in addition to implementing high standards of quality control, it is in the interest of the entire biopesticide industry to provide stewardship for all products on the market.

The development of bacterial insectcides has experienced up and down cycles. During the past several years, there have been significant changes in the companies which engage in the development and commercialization of bacteria insecides. Commercialization of products other than Bacillus thuringiensis (Bt) have limited success. Bt based formulations remain the main products in this field Other bacteria failed in the market place due to (1) production issues, (2) market size, (3) efficacy, (3) competition, (4) stability and (5) registration costs etc. Quality control of bacterial insecticides includes the passage of multiple physical properties and the assurance of insect killing power or potency of a formulation. The potency of Bt based insecticides is generally estimated by bioassy, i.e. the measuement of the dose rsponse of target insect to a formulation in comparison to a recognized standard of know potency. There are successes and issues of using alternative methods other than bioassay to determine potency. The limitations of using the alternative methods will be presented and discussed.

Within the last two years the Policy Support Action REBECA reviewed currently existing regulation of microbial biocontrol agents and made proposals for improved procedures to accelerate registration and reduce costs while maintaining the high level of safety for users and consumers. In general, REBECA recommended to introduce or maintain the practice of presubmission meetings to define which data are required. Apart from many general proposals for improvement and acceleration of the registration process the Action also provided recommendations specific to microbial biocontrol agents and viruses. The high similarity between baculoviruses justifies a general assessment at the level of the family Baculoviridae.For products containing bacteria and fungi, the action defined a short list of data, which should be available for a pre-submission meeting in order to be able to decide on data requirements and waivers. Major concerns exist about how to handle the risk assessment of microbial metabolites. These substances usually have a very short half-life and are generally produced in small quantifies, why many participants of the Action did not consider metabolites of microbials used in biocontrol to pose riks to humans and the environment. A short trak decision pathway was developed for risk assessment of metabolites. Data requirements on effects on earthworms and soil microbiota should be generally waived because hazards are very unlikely. Infectivity studies should be waived when all of the following requirements are met: no clinical reports, not listed in 2001/54 EC, humans and animals are already regularly exposed to the micro-organism, susceptibility to antibiotics. Data requirements regarding the instability of genetic traits affecting the efficacy of the product should be waived or removed because this will be checked by quality control. Data requirements on fate and behaviour in the environment should be waived for micro-organisms which are already part of the background population.

The market for products based on biological control agents (BcAs) has been increasing steadily over the past few years at a much faster rate than that of chemical plant protection products. This market will continue to increase in the future as a result of several factors: growth of the niche market of high value crops, withdrawal and/or restrictions in the use of chemical pesticides, ecotoxicological issues, restrictions concerning minimum detectable residue levels in the final produce, consumer awareness, and consequently increased adoption of IPM and sustainable farming strategies. Unfortunately, up to now, the registration process has been completed successfully for only a limited number of BcAs, and for an even lower number full commercial development has been achieved. Several factors, especially regulatory constraints, can negatively affect the successful development and commercialization of cost-effective BcA-based products. A detailed analysis of the different factors involved will be presented.