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As the main impetus for regulating microorganisms is to reach an acceptable level of safety with respect to human health and environment, the main aim of the book is instead to critically examine the safety principles that have governed the development of regulations in representative countries, and to what extent these correctly mirror actual hazards and risks. After an introductory chapter by the editors, the book starts with chapters treating regulatory systems for typical application areas in representative jurisdictions. These are followed by others discussing various approaches for assessing the safety of microbes and their utilization, as well as new methodologies to determine pathogenicity, virulence and toxicity. Special chapters examine how international initiatives and agreements as well as public 'risk perception' can influence the implementation of microbial solutions to environmental or agricultural problems.

The aim of this study was to identify reasons why the authorization of microbial pest control agents is lengthier under regulatory frameworks of the European Union (EU) than in comparable jurisdictions. A main conclusion is that although the EU and apos;s regulatory processes have strong scientific foundations, the most appropriate scientific concepts, knowledge and expertise have not been applied in the safety assessment of microorganisms and biological control. Tradition and conceptual legacies from assessments of conventional chemical pesticides have likely contributed to this by steering the evaluations of microorganisms in less appropriate directions. According to our investigation, the current framework for microbial plant protection products complies poorly with the principles that legislation should have legal predictability, proportionality, and that it should be non-discriminative, for instance in comparison to corresponding regulations in comparable jurisdictions. We also found that existing possibilities to take non-safety and ethical considerations into account can probably be used more. To rationalize the EU and apos;s authorization of microbial control products, both the basic legislation and the evaluations of agents and products need stronger rooting in fundamental microbiological science. (c) 2020 The Authors. Pest Management Science published by John Wiley and Sons Ltd on behalf of Society of Chemical Industry.

The aim of this study was to identify reasons why the authorization of microbial pest control agents is lengthier under regulatory frameworks of the European Union (EU) than in comparable jurisdictions. Amain conclusion is that although the EU's regulatory processes have strong scientific foundations, the most appropriate scientific concepts, knowledge and expertise have not been applied in the safety assessment of microorganisms and biological control. Tradition and conceptual legacies from assessments of conventional chemical pesticides have likely contributed to this by steering the evaluations of microorganisms in less appropriate directions. According to our investigation, the current framework for microbial plant protection products complies poorly with the principles that legislation should have legal predictability, proportionality, and that it should be non-discriminative, for instance in comparison to corresponding regulations in comparable jurisdictions. We also found that existing possibilities to take non-safety and ethical considerations into account can probably be used more. To rationalize the EU's authorization of microbial control products, both the basic legislation and the evaluations of agents and products need stronger rooting in fundamental microbiological science.

The aim of this study was to identify reasons why the authorization of microbial pest control agents is lengthier under regulatory frameworks of the European Union (EU) than in comparable jurisdictions. A main conclusion is that although the EU's regulatory processes have strong scientific foundations, the most appropriate scientific concepts, knowledge and expertise have not been applied in the safety assessment of microorganisms and biological control. Tradition and conceptual legacies from assessments of conventional chemical pesticides have likely contributed to this by steering the evaluations of microorganisms in less appropriate directions. According to our investigation, the current framework for microbial plant protection products complies poorly with the principles that legislation should have legal predictability, proportionality, and that it should be non‐discriminative, for instance in comparison to corresponding regulations in comparable jurisdictions. We also found that existing possibilities to take non‐safety and ethical considerations into account can probably be used more. To rationalize the EU's authorization of microbial control products, both the basic legislation and the evaluations of agents and products need stronger rooting in fundamental microbiological science. © 2020 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Within food plant cropping systems, microorganisms provide vital functions and ecosystem services, such as biological pest and disease control, promotion of plant growth and crop quality, and biodegradation of organic matter and pollutants. The beneficial effects of microorganisms can be achieved and/or enhanced by agricultural management measures that target the resident microbial biodiversity or by augmentation with domesticated and propagated microbial strains. This study presents a critical review of the current legislation and regulatory policies pertaining to the utilization of plant-beneficial microorganisms in the European Union (EU). For augmentative approaches, the nature of the intended effect and the product claim determine how a microbiological product is categorized and regulated, and pre-market authorization may be mandatory. Typically, microbial products have been incorporated into frameworks that were designed for evaluating non-living substances, and are therefore not well suited to the specific properties of live microorganisms. We suggest that regulatory harmonization across the sector could stimulate technical development and facilitate implementation of crop management methods employing microorganisms. Possible scenarios for regulatory reform in the longer term are discussed, but more investigation into their feasibility is needed. The findings of this study should serve as a catalyst for more efficient future use of plant-beneficial microorganisms, to the benefit of agriculture as well as the environment.

Within food plant cropping systems, microorganisms provide vital functions and ecosystem services, such as biological pest and disease control, promotion of plant growth and crop quality, and biodegradation of organic matter and pollutants. The beneficial effects of microorganisms can be achieved and/or enhanced by agricultural management measures that target the resident microbial biodiversity or by augmentation with domesticated and propagated microbial strains. This study presents a critical review of the current legislation and regulatory policies pertaining to the utilization of plant-beneficial microorganisms in the European Union (EU). For augmentative approaches, the nature of the intended effect and the product claim determine how a microbiological product is categorized and regulated, and pre-market authorization may be mandatory. Typically, microbial products have been incorporated into frameworks that were designed for evaluating non-living substances, and are therefore not well suited to the specific properties of live microorganisms. We suggest that regulatory harmonization across the sector could stimulate technical development and facilitate implementation of crop management methods employing microorganisms. Possible scenarios for regulatory reform in the longer term are discussed, but more investigation into their feasibility is needed. The findings of this study should serve as a catalyst for more efficient future use of plant-beneficial microorganisms, to the benefit of agriculture as well as the environment.

Within food plant cropping systems, microorganisms provide vital functions and ecosystem services, such as biological pest and disease control, promotion of plant growth and crop quality, and biodegradation of organic matter and pollutants. The beneficial effects of microorganisms can be achieved and/or enhanced by agricultural management measures that target the resident microbial biodiversity or by augmentation with domesticated and propagated microbial strains. This study presents a critical review of the current legislation and regulatory policies pertaining to the utilization of plant-beneficial microorganisms in the European Union (EU). For augmentative approaches, the nature of the intended effect and the product claim determine how a microbiological product is categorized and regulated, and pre-market authorization may be mandatory. Typically, microbial products have been incorporated into frameworks that were designed for evaluating non-living substances, and are therefore not well suited to the specific properties of live microorganisms. We suggest that regulatory harmonization across the sector could stimulate technical development and facilitate implementation of crop management methods employing microorganisms. Possible scenarios for regulatory reform in the longer term are discussed, but more investigation into their feasibility is needed. The findings of this study should serve as a catalyst for more efficient future use of plant-beneficial microorganisms, to the benefit of agriculture as well as the environment.

Microbial control agents (MCAs) are promising for use in sustainable agriculture. Nevertheless, they face a major hurdle in the registration process of the European Union, one reason being unclear data requirements on metabolites. This review examines the EU regulatory perspective on metabolites of MCAs for plant protection and identifies some key issues and concerns. Current data requirements for secondary metabolites of micro-organisms are based on degradation products/metabolites of chemicals. We conclude that this has contributed strongly to the current confusion regarding how to best evaluate potential production of toxic substances by MCAs. We suggest that data requirements should be revised and/or need guidance fit for purpose, in order to give the EU-regulation for MCAs a stronger base in microbiological knowledge. We also suggest implementation of a basic hazard assessment. If this is passed without any concerns, the production of unknown, potentially toxic, substances does not need to be further investigated.

Biological control, or biocontrol, is the exploitation of living agents (incl. viruses) to combat pestilential organisms (incl. pathogens, pests, and weeds) for diverse purposes to provide human benefits. Thus, during the last century the practices and concepts involved have evolved in separate streams associated with distinct scientific and taxonomic disciplines. In parallel developments, there have been increasing references to biological control in industrial contexts and legislation, resulting in conceptual and terminological disintegration. The aim of this paper is to provide a global conceptual and terminological platform that facilitates future development of the field. We review use of previously suggested terms in key fields (e.g., phytopathology, entomology, and weed science), eliminate redundant terminology, identify three principles that should underpin the concept, and then present a new framework for biological control, rooted in seminal publications. The three principles establish that (1) only living agents can mediate biological control, (2) biological control always targets a pest, directly or indirectly, and (3) all biocontrol methods can be classified in four main categories depending on whether resident agents are utilized, with or without targeted human intervention (conservation biological control and natural biological control, respectively) or agents are added for permanent or temporary establishment (classical biological control and augmentative biological control, respectively). Correct identification of what is, and is not, biological control can help efforts to understand and optimize biological pest control for human and environmental benefits. The new conceptual framework may contribute to more uniform and appropriate regulatory approaches to biological control, and more efficient authorization and application of biocontrol products.

Fokusgruppens syfte har varit att definiera kunskapsluckor avseende den praktiska användningen och implementeringen av alternativa medel med låg risk för bekämpning av skadegörare och sjukdomar inom jordbruk, trädgårdsodling och skogsbruk. Vi har utgått från en bred definition av medel med låg risk, som har omfattat både allmänkemikalier och växtskyddsmedel med låg risk (enligt gällande EU-lagstiftning). Trots att det idag finns ett ökat behov av alternativa verktyg inom växtskyddet och politiska mål om minimerad användning av kemiska medel, så är användningen av alternativa bekämpningsmedel i fältodlade grödor mycket begränsad. • En viktig faktor som styr och begränsar tillgängligheten av alternativa medel är EU-lagstiftningen för godkännande av dessa medel. För att kunna registrera ett medel behövs en investering från det företag som ansöker om godkännande, vilket kan vara en anledning till att medel inte blir tillgängliga på marknaden. En annan lagteknisk begränsning är ogynnsamma skatteregler för dessa medel. • Från ett användarperspektiv är bristande kunskap om hur effektiva dessa medel är, hur man bäst applicerar dem samt hur de kan integreras i befintliga växtskyddsstrategier en bidragande orsak till att de inte används fullt ut. • Rådgivningen pekar också på en otydlighet om vilka medel som får användas speciellt i ekologisk produktion och att användningen missgynnas av höga priser i kombination med en osäkerhet om hur effektiva dessa medel är. • I Jordbruksverkets rapport "Hinder för ökad användning av alternativa bekämpningsmedel" (SJV, Rapport 2019:3), som medlemmar av fokusgruppen har varit med att skriva, är ett av förslagen en utökad rådgivningsverksamhet. Detta eftersom informationsinsatser och aktiv rådgivning kan påverka hur snabbt odlare accepterar och börjar använda ett växtskyddsmedel, speciellt om det har nya egenskaper (och en ny verkningsmekanism). Forskning visar att en ny åtgärd/metod inte bara ska Sammanfattning och slutsatser 5 passa in i befintliga verksamheter utan också passa med attityd och värderingar hos användaren. • Från ett forskningsperspektiv kan vi se ett klart behov av tillämpningsnära forskning framför allt för att få en ökad kunskap om hur alternativa bekämpningsmedel kan integreras i befintliga växtskyddsstrategier. En utmaning är den begränsade mängd forskningsmedel som finns att söka för denna typ av forskning. • Forskningen är ofta väldigt uppdelad mellan agrikultur, hortikultur och skogsbruk. Här skulle man kunna dra nytta av kunskap inom respektive system eftersom vissa aspekter är generella mellan olika system, åtminstone för vissa grödor/träd. • Från ett internationellt perspektiv kan vi se vinster med ett bättre samarbete med närliggande länder, tex Plant Biologicals Network (PBN) som koordineras från Danmark, men även engagemang inom det vidare EUperspektivet (bla lagar). • Ytterligare en slutsats från fokusgruppens arbete är att växtskyddsforskningen på SLU behöver samordnas bättre, tex genom att knyta samman de kompetenscentrum som finns idag – CBC och CKB – med nya strukturer som skulle kunna fokusera på i) analys av växtskadegörare och ii) lågrisk-metoder och hur dessa kan spela en roll i integrerat växtskydd (IPM). • ygarbeta tillsammans för att få till en bra samverkan och kunskapsutbyte.