Literature search and data collection on RA for human health for microorganisms used as plant protection products

Abstract

A knowledge base of scientific and regulatory data relevant in the context of risk assessment of microbial plant protection products (PPPs) for human health was established, taking into consideration conditions 1 to 4 in Regulation (EU) 546/2011 that must be met before authorisation can be granted. We screened scientific publications and documents from governmental and institutional sources and extracted relevant information into a database, performed comparative genome analyses to explore possibilities and limitations of applying read-across among PPP strains, and discussed the collective findings among a group of experts in relevant fields. Besides information on factors relevant for the evaluation of microbial PPP strains regarding pathogenicity, infectivity, and toxicity, information was collected on methods used to analyse the PPP species' ability to persist and grow in test animals, for detecting microbial DNA transfer, for testing microbial compounds for potential toxicity, and for detecting toxin production from PPP strains. Questions arising from the reviewed scientific and grey literature were how to address the specific biological properties of PPP strains and how to take into consideration realistic exposure scenarios and a natural background of environmental microorganisms in the risk assessment. Results from the present work imply that pathogenicity traits have to be considered as strain specific and that, hence, read-across comparison cannot be used. From a scientific point of view, it was highly recommended to provide whole genome sequencing data of PPP strains to allow their unambiguous identification, while other technological developments such as the use of metabolomics data were seen as an option for future implementation. It is envisaged to further develop the key topics of the present work at a joint stakeholder workshop as the next step towards the preparation of a guidance document by the PPR panel on how to conduct the regulatory risk assessment for microbial pesticides. © Efsa 2015Key words: microorganism, pesticide, risk assessment, human health, toxicity, read-across, DNA sequencing Disclaimer: The present document has been produced and adopted by the bodies identified above as authors. This task has been carried out exclusively by the authors in the context of a contract between the European Food Safety Authority and the authors, awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.Suggested citation: Evelyn Hackl1), Margit Pacher-Zavisin2), Laura Sedman1), Stefan Arthaber1), Ulla Bernkopf1), Günter Brader1), Markus Gorfer1), Birgit Mitter1), Aspasia Mitropoulou1), Monika Schmoll1), Willem van Hoesel1), Elisabeth Wis...

Why has the authorization of microbial biological control agents been slower in the EU than in comparable jurisdictions?

“…As an alternative to updating the basic legislation, a more efficient strategy might be to produce and update, on a more regular basis, documents providing guidance for applying the DRs and performing the assessments in practice. We note that while the European Food Safety Authority (EFSA) supported two systematic reviews on environmental and human safety assessment of microbial PPPs, 50,51 and regularly provide updated guidance on various scientific aspects of risk assessment and authorization of microorganisms in, for example, animal feed, 52 and of chemical PPPs, 53 EFSA do not develop guidance for evaluations of microbial PPPs.…”