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Registration of Microbial Pest Control Agents and Products and Other Related Regulations

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A Roadmap to the Successful Development and Commercialization of Microbial Pest Control Products for Control of Arthropods

Part of the book series: Progress in Biological Control ((PIBC,volume 10))

Abstract

Several regulations apply to the handling and the use of microbial pest control agents. Microorganisms used for control of pests are subject to registration as a “plant protection product”. The history of the development of data requirements for entomopathogens is presented. Current registration requirements are reviewed, particularly for the European Union. For several topics, data requirements are unclear or even lacking; procedures are both long and expensive. Initiatives to ameliorate these impediments are reviewed. The EU project REBECA provided recommendations for improvement of procedures as well for data requirements. The OECD BioPesticides Steering Group continues this work and is developing guidance for several data requirements issues. A general estimate of costs for the generation of a registration dossier is provided.

Entomopathogenic nematodes are not covered by the legislation of plant protection products in the EU. Several countries, however, have a registration for macroorganisms in place. Regulations for import and for export, and for release of macroorganisms have become complex and an administrative burden for biocontrol companies. The current situation in the Netherlands is highlighted as an example.

Various other regulations, such as laws on biodiversity, importation and release of exotic organisms, and safe handling apply to the use of microorganisms, and are briefly treated. Intellectual property rights are important for a company. The possibility to obtain a patent for a biopesticide and the value thereof will be discussed. Regulations form a major obstacle in the commercialization of biopesticides. Recommendations for improvements are presented for data requirements and for regulatory procedures. The role that the biocontrol industry should have in this political field is outlined.

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Ravensberg, W.J. (2011). Registration of Microbial Pest Control Agents and Products and Other Related Regulations. In: A Roadmap to the Successful Development and Commercialization of Microbial Pest Control Products for Control of Arthropods. Progress in Biological Control, vol 10. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-0437-4_5

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