Les produits phytopharmaceutiques, communément appelés pesticides, sont utilisés pour lutter contre les organismes nuisibles aux plantes et, ce faisant, assurer les rendements agricoles et les approvisionnements alimentaires. L'encadrement juridique français de ces produits s'est donc d'abord intéressé à garantir leur efficacité. Dans un second temps seulement, il a cherché à limiter les risques qu'ils présentent pour la santé et l'environnement. Depuis la stratégie thématique communautaire sur l'utilisation durable des pesticides, l'objectif qui lui est assigné est plus ambitieux, car il s'agit de réduire la dépendance de l'agriculture aux pesticides. Au-delà de la réduction des quantités de produits utilisées, il devient alors nécessaire d'adopter de nouvelles pratiques de lutte et, plus encore, de nouvelles méthodes agronomiques permettant de prévenir l'apparition et le développement des nuisibles. Or, les règles relatives à la mise sur le marché des produits phytopharmaceutiques, coeur du dispositif juridique, si elles réduisent le niveau de risque acceptable pour la santé et l'environnement des pesticides, peinent à atteindre cet objectif. Il en va de même du nouvel encadrement de l'utilisation des pesticides, pourtant plus prometteur. Pour réorienter les pratiques agricoles, il s'avère nécessaire de faire appel aux ressources de l'ensemble du droit agricole. Or, qu'il s'agisse du recours aux instruments de marché ou du cadre très structurant de la politique agricole commune, l'intégration, certes croissante, des préoccupations sanitaires et environnementales reste à un niveau encore insuffisant pour modifier substantiellement les pratiques. / Plant protection products, also known as pesticides, are used to fight against offensive organisms on plants. By doing so, they also guarantee crop yield and food supplying. French legal framework has been genuinely built to ensure market efficiency to these products even before trying to limit their impact on health and environment. With the community thematic strategy on sustainable use of pesticides, its objective gets more aspiring as it now concerns the reduction of farming dependency on pesticides. But more than reducing the use of these products, it becomes necessary to implement new practices. Moreover, new agronomical methods have to be set up against pest emergence and its uncontrolled growth. Although market rules on plant protection products, which are in the core of the legal package, do lower the risk on health and environment, they hardly reach this goal. It is the same analysis with the yet promising legal framework on pesticides use. Calling on the entire resources of agricultural law becomes necessary in order to redirect farming practises. In spite of the help from both market instruments and the very structuring framework of the common agricultural policy, the growing integration of health and environmental concern stays at an unsufficient level to substantially change these practices.

Os avanços na mecanização agrícola têm contribuído para o crescimento da produtividade agrícola do país, garantindo ao Brasil lugar de destaque na produção agrícola de alimentos, fibras e energia. A aplicação de produtos fitossanitários tem contribuído para esse aumento garantindo a proteção de plantas dentro do ciclo de produção agrícola. Controladores eletrônicos têm sido utilizados nas aplicações de produtos fitossanitários na agricultura moderna, surgindo à necessidade de estudos do seu desempenho. O tempo de resposta é o principal parâmetro, pois determina a eficiência do sistema de controle. Desta forma, objetivo deste trabalho foi estudar o tempo de resposta de um controlador eletrônico de pulverização variando as velocidades de deslocamento e taxas de aplicação, em baixas, médias e altas vazões. As mudanças de velocidade de deslocamento e as de taxa de aplicação influenciaram nos tempos de resposta no controlador eletrônico de pulverização. Os tempos de resposta obtidos do controlador eletrônicos de pulverização para mudanças de velocidade e taxa de aplicação variaram de 2 a 9 e 1,5 a 8 segundos respectivamente. A exatidão do sistema de controle eletrônico de pulverização para as mudança de velocidade foi de ± 2% e para as mudanças de taxas de aplicação de ± 4%. O controlador eletrônico de pulverização obteve menor tempo resposta em altas vazões e maiores velocidades. / Advances in agricultural mechanization contributed to the growth of productivity in the country farms, leading Brazil to a significant position in the agricultural production of food, fibre and energy. A fraction of these results had been ensured by employment of plant protection products within the cycle of agricultural production. In this context, electronic controllers have been used in spraying applications and creating a demand for studies of their performance. Response time in actual applications is a key parameter determining the efficiency of the control system. The objective of this work was to study the response time of an electronic controller of: varying displacement speeds, spraying, and application rates; working at low, medium and high flows. Influences in the response time were found for speed changes and the application rates in spray electronic controller. Ranging from 2 to 9 and 1.5 to 8 seconds respectively. The accuracy of electronic spray control system for gear change was up to 2% and to changes in application rates up to 4%. Time responses for the electronic controller were lower for high flow rates and speeds.

Os avanços na mecanização agrícola têm contribuído para o crescimento da produtividade agrícola do país, garantindo ao Brasil lugar de destaque na produção agrícola de alimentos, fibras e energia. A aplicação de produtos fitossanitários tem contribuído para esse aumento garantindo a proteção de plantas dentro do ciclo de produção agrícola. Controladores eletrônicos têm sido utilizados nas aplicações de produtos fitossanitários na agricultura moderna, surgindo à necessidade de estudos do seu desempenho. O tempo de resposta é o principal parâmetro, pois determina a eficiência do sistema de controle. Desta forma, objetivo deste trabalho foi estudar o tempo de resposta de um controlador eletrônico de pulverização variando as velocidades de deslocamento e taxas de aplicação, em baixas, médias e altas vazões. As mudanças de velocidade de deslocamento e as de taxa de aplicação influenciaram nos tempos de resposta no controlador eletrônico de pulverização. Os tempos de resposta obtidos do controlador eletrônicos de pulverização para mudanças de velocidade e taxa de aplicação variaram de 2 a 9 e 1,5 a 8 segundos respectivamente. A exatidão do sistema de controle eletrônico de pulverização para as mudança de velocidade foi de ± 2% e para as mudanças de taxas de aplicação de ± 4%. O controlador eletrônico de pulverização obteve menor tempo resposta em altas vazões e maiores velocidades. / Advances in agricultural mechanization contributed to the growth of productivity in the country farms, leading Brazil to a significant position in the agricultural production of food, fibre and energy. A fraction of these results had been ensured by employment of plant protection products within the cycle of agricultural production. In this context, electronic controllers have been used in spraying applications and creating a demand for studies of their performance. Response time in actual applications is a key parameter determining the efficiency of the control system. The objective of this work was to study the response time of an electronic controller of: varying displacement speeds, spraying, and application rates; working at low, medium and high flows. Influences in the response time were found for speed changes and the application rates in spray electronic controller. Ranging from 2 to 9 and 1.5 to 8 seconds respectively. The accuracy of electronic spray control system for gear change was up to 2% and to changes in application rates up to 4%. Time responses for the electronic controller were lower for high flow rates and speeds.

Pharmaka werden nach ihrer Einnahme bzw. Verabreichung über verschiedene Pfade in die Umwelt eingetragen. Obwohl Arzneimittel zu den toxikologisch best-untersuchten und -charakterisierten Stoffen gehören, ist ihre Wirkung auf die Umwelt und die darin lebenden Organismen weit weniger gut untersucht. Wenn in der Literatur Daten zur Ökotoxizität vorhanden sind, so beziehen sich diese meist nur auf die Wirkung von Einzelstoffen. In der Umwelt sind die Organismen jedoch gegenüber Mischungen exponiert. Aufgrund der geschilderten Problematik wurden eine Reihe von Arzneimitteln unterschiedlicher Indikationsgruppen einzeln und in Kombination mit dem Embryotest mit dem Zebrabärbling (Danio rerio, DarT) untersucht. Dieses Testsystem wurde durch Schulte & Nagel (1994) als Alternativmethode zum akuten Fischtest nach OECD 203 entwickelt und bietet den Vorteil neben letalen auch eine Reihe von subletalen Endpunkten erfassen zu können. Es handelt sich zudem nach dem deutschen Tierschutzgesetz nicht um einen Tierversuch. Die generelle Vergleichbarkeit der ermittelten Werte mit Daten aus akuten Fischtests nach OECD 203 sowie die Anwendbarkeit für verschiedenste Fragestellungen konnten in einer Reihe von Studien gezeigt werden (Nagel, 2002). Für die hier vorgestellten Untersuchungen wurden zunächst 32 Pharmaka und drei Pflanzenschutzmittel als Einzelstoffe mit dem DarT untersucht. Basierend auf den Ergebnissen der Einzelstofftests wurden Mischungen sowohl aus Substanzen mit ähnlichen als auch unähnlichen Wirkmechanismen getestet. Es zeigte sich, dass unabhängig vom Wirkmechanismus die Mischungstoxizität durch das Konzept der Konzentrationsadditivität gut vorhergesagt wurde, während das Konzept der Unabhängigen Wirkung die Mischungstoxizität unterschätzte. Ebenfalls konnte gezeigt werden, dass die Kombination der Stoffe auf Basis der NOEC, die im DarT anhand der Herzschlagfrequenz nach 48 Stunden ermittelt wird, zu deutlichen Mischungseffekten führt.

Cette thèse porte sur la régulation des innovations en Europe. Elle examine en particulier l'impact économique des procédures d'Autorisation de Mise sur le Marché (AMM) sur les comportements des acteurs économiques à savoir les firmes innovantes. Il s'agit d'un travail appliqué au secteur de la santé des plantes dans lequel l'AMM joue un rôle central. En effet, dans ce secteur, la mise sur le marché des pesticides est subordonnée à une autorisation officielle. Les procédures d'autorisation de mise sur le marché (AMM) des nouveaux produits consistent à vérifier qu'ils n'ont pas d'effets toxiques inacceptables sur la santé et l'environnement et à définir des conditions d'utilisation dans lesquelles ces produits sont réputés efficaces. En Europe, ces procédures sont instruites par des autorités européennes ou nationales. Dans le cas des pesticides, les matières actives sont autorisées à l'échelle européenne, les spécialités commerciales le sont à l'échelle nationale, par reconnaissance mutuelle au sein d'une zone géographique. Au cours des dernières décennies, les exigences dans le domaine des risques sanitaires ont conduit à un renforcement des contraintes imposées pour la mise en marché des produits phytosanitaires. Ces exigences renforcées ont conduit à une réduction du nombre de molécules autorisées en rapport au nombre de molécules potentiellement efficaces. Par exemple, le nombre de molécules pesticides autorisées a été réduit de moitié (de 800 à 400) au cours des dix dernières années. C'est pourquoi, l'objet principal de cette recherche est d'étudier les effets des procédures d'AMM sur le comportement des firmes agrochimiques. Cette recherche s'articule autour de trois chapitres. Le premier chapitre est théorique. Il analyse les interactions stratégiques entre les agences de régulation des pesticides dans un contexte d'autorisation de mise sur le marché par reconnaissance mutuelle. Le chapitre 2 est à la fois théorique et empirique et porte sur les délais de mise sur le marché des substances actives phytosanitaires. Dans le chapitre 3, nous examinons, à l'aide d'un modèle théorique, l'impact de la régulation des pesticides sur les incitations des firmes agrochimiques à investir en R&D. / This thesis focuses on the regulation of innovations in Europe. In particular, it analyses the economic impact of the market approval procedures on the behavior of economic actors such as innovative firms. This is an applied work in the health sector of plants in which the market approval procedures play a central role. Indeed, in this area, the introduction on the market of pesticides is subject to an official approval. The market approval procedures for new products are to ensure that they do not have unacceptable toxic effects on human health and the environment and to define the conditions of use in which these products were efficient. In Europe, these procedures are investigated by European or national authorities. In the case of pesticides, the active substances are approved at EU level and the pesticides formulation at the national level through mutual recognition within a geographic area. In recent decades, the requirements in the field of health risks have led to a strengthening of the constraints imposed on the approval of pesticides. These stringent requirements have led to a reduction in the number of approved molecules relative to the number of molecules potentially efficient. For example, the number of approved actives substances was reduced by half (800 to 400) over the last ten years. Therefore, the main purpose of this research is to study the effects of market approval procedures on the behavior of agrochemical companies. This research is based on three chapters. The first chapter is theoretical. It analyses the strategic interactions between pesticide regulatory agencies in the context of market approval through the mutual recognition system. The chapter 2 is both a theoretical and an empirical work. It examines the examination delays of plant protection active substances. In Chapter 3, we examine, using a theoretical model, the impact of the regulation of pesticides on the incentives of agrochemical companies to invest in R & D.

This diploma thesis focuses on the statistical examination of properties of plant protection products at Agro-Artikel, s.r.o. Using the empirical distribution function, it focuses on the sales price and the shelf life of the products, tests the hypotheses about the properties of the products and the dependencies between them. The thesis also explores the results of the questionnaire survey and offers recommendations for the introduction of new products.

Molte attività antropiche danno origine a problemi ambientali per i quali è necessario trovare soluzioni. La presenza di sostanze indesiderabili nell'acqua, infatti, può rappresentare un rischio per la salute e l'igiene sia degli uomini che degli animali. È quindi fondamentale trovare metodi per evitare gli inquinanti di queste matrici, in modo da renderli compatibili con il mantenimento di condizioni ambientali adeguate e salutari. Questa tesi si propone di valutare la qualità delle acque sotterranee di un'area in cui la qualità dell'acqua non è mai stata studiata, in particolare indagando la presenza di pesticidi e nitrati al fine di comprendere l’impatto della viticoltura sull'inquinamento delle acque sotterranee. Questo studio nasce dalla necessità di migliorare la governance delle acque e di implementare le migliori pratiche di gestione e misure di mitigazione per prevenire l'inquinamento delle acque e quello ambientale. I risultati degli studi di monitoraggio hanno mostrato una contaminazione delle acque sotterranee da parte di pesticidi e nitrati e quindi è stata effettuata una valutazione della fonte di contaminazione da pesticidi e nitrati attraverso studi isotopici di N e O di NO3-, e attraverso analisi idrologiche utilizzando il modello CRITERIA 3D. Come una delle principali conclusioni del lavoro si può affermare che la presenza di pesticidi nelle acque sotterranee in un’area ad attività vitivinicola intensa, non può essere correlata solo alle proprietà e al destino chimico-ambientale delle sostanze o alle condizioni pedoclimatiche, ma anche al comportamento dell'utilizzatore finale. In effetti, la fonte di contaminazione valutata, è risultata essere dovuta sia a una contaminazione diffusa che a una contaminazione puntiforme. Per quanto riguarda l'influenza della fertilizzazione a base di azoto sulla presenza di nitrati nelle acque sotterranee, i risultati hanno mostrato un'elevata vulnerabilità dell'acquifero ai cambiamenti esterni. Dalle indagini isotopiche è emerso che la maggior parte dell'NO3- rilevato nelle acque sotterranee, deriva dall'utilizzo di fertilizzanti azotati inorganici, in accordo con le pratiche di uso del suolo e di viticoltura dichiarate dagli agricoltori della zona. Il risultato più importante dello studio, tuttavia, è stato che alla fine del processo, l'approccio multi-actor e la strategia di coinvolgimento adottati, hanno avuto successo nel migliorare gli atteggiamenti verso pratiche più sostenibili. / Many anthropic activities give rise to environmental problems for which it is necessary to find solutions. The presence of undesirable substances in water, indeed, can pose a risk to the health and hygiene of both men and animals. It is, therefore, essential to find methods in order to avoid pollutants from these matrices, so as to make them compatible with the maintenance of healthy environmental conditions. This thesis aims to assessing the groundwater quality of an area in which the quality of water was never studied, particularly investigating the occurrence of pesticides and nitrate in order to understand the grant of viticulture on water pollution. This study derives from the necessity to improve the water governance and to implement the best management practices and mitigation measures to prevent groundwater and environmental pollution. The results of monitoring studies showed a contamination of groundwater by pesticides and nitrate and thus an evaluation of PPPs and nitrates source contamination was carried out through isotopic studies of N and O of NO3- , and through hydrologic analysis by use of the model CRITERIA 3D. As one of the main conclusions of the work, the occurrence of PPPs in groundwater in areas with intensive viticultural activities cannot be related just to chemical environmental fate properties or pedoclimatic conditions, but also to end-user behavior. In fact, the contamination source evaluated, resulted to be due to both diffuse and point-source contamination. For what concerns the influence of nitrogen-based fertilization on nitrate occurrence in groundwater, the results showed a high vulnerability of the aquifer to external changes. Isotopic investigations showed that most of the NO3- detected in the groundwater, derived from the use of inorganic nitrogen fertilizers, in agreement with the land use and viticulture practices declared by the farmers. The most important result of the study, however, was that at the end of the overall process, the multi-actor approach and engagement strategy adopted were successful in improving attitudes to more sustainable practices.

La prima parte dell’elaborato presenta le origini e lo sviluppo delle politiche di valutazione del rischio per le sostanze chimiche. Dopo un primo inquadramento storico, l’attenzione è stata dedicata a temi emergenti come la valutazione delle incertezze, la necessità di integrazione delle valutazioni del rischio per l’uomo e per l'ambiente. La seconda parte presenta l’evoluzione delle politiche di valutazione del rischio dei prodotti fitosanitari, soprattutto a livello europeo (dall’applicazione della direttiva 91/414 all’attuale regolamento 1107/2009), con particolare attenzione all’applicazione del principio di precauzione. Il terzo capitolo approfondisce le fasi e gli approcci delle attuali procedure di valutazione ambientale del rischio dei pesticidi usati a livello europeo e americano; è stato in particolar modo esplorato il tema dell’individuazione degli obiettivi specifici di protezione in fase preliminare di valutazione del rischio. Il quarto capitolo tratta di un tema attualmente molto dibattuto, ovvero la valutazione dei potenziali effetti combinati sugli organismi non bersaglio esposti a più sostanze attive simultaneamente. Infine, l’obiettivo del quinto capitolo è quello di valutare la contaminazione ambientale dovuta all’applicazione di fungicidi a base rame su melo. A tale scopo è stato testato un nuovo modello per il calcolo integrato dell’esposizioni umana e ambientale MERLIN – Expo, sviluppato grazie al progetto europeo 4FUN. I risultati ottenuti per le acque superficiali e il sedimento sono stati confrontati con i risultati degli attuali modelli usati in Unione Europea, i modelli FOCUS. Le simulazioni probabilistiche hanno anche permesso di effettuare valutazioni di incertezza e sensitività sui parametri utilizzati nelle simulazioni. / This PhD thesis is a multidisciplinary work on the risk assessment of plant protection products including both legislative and scientific aspects. The first part of the thesis introduces the origin of risk assessment procedures with a wide glance on the whole process of risk analysis to protect the humans and the environment. The accent is put on emerging issues and trends, such as the uncertainties appraisal, the necessity of integration between human and environmental impacts without ignoring socio- economic and behavioural factors. The second chapter deals with the origin and development of global risk assessment policies on pesticides. It focuses in particular on European policies, from the original Directive 91/414 to the current Regulation 1107/2009 and the application of the precautionary principle. A brief comparison with US approaches for risk assessment is also presented. The third chapter gives an overview on the risk assessment procedures that nowadays provide the highest achievable protection for the environment, starting with the definition of clear and specific protection goals. The fourth chapter addresses the issue of combined risk assessment of pesticides: current approaches for the evaluation of effects on non-target organisms are analysed. The last chapter is dedicated to the estimation of the environmental contamination following the application of copper –based fungicides sprayed on orchards by using MERLIN - Expo, which is a multimedia model developed in the frame of the FP7 EU project 4FUN. The performance of the MERLIN- Expo software in estimating the contamination of the metal is also analysed through a comparison with the currently used FOCUS standard models for the calculation of pesticides concentrations in surface water and sediment. Both deterministic and probabilistic simulations have been run; the latter has allowed to perform uncertainty and sensitivity assessment.

Pharmaka werden nach ihrer Einnahme bzw. Verabreichung über verschiedene Pfade in die Umwelt eingetragen. Obwohl Arzneimittel zu den toxikologisch best-untersuchten und -charakterisierten Stoffen gehören, ist ihre Wirkung auf die Umwelt und die darin lebenden Organismen weit weniger gut untersucht. Wenn in der Literatur Daten zur Ökotoxizität vorhanden sind, so beziehen sich diese meist nur auf die Wirkung von Einzelstoffen. In der Umwelt sind die Organismen jedoch gegenüber Mischungen exponiert. Aufgrund der geschilderten Problematik wurden eine Reihe von Arzneimitteln unterschiedlicher Indikationsgruppen einzeln und in Kombination mit dem Embryotest mit dem Zebrabärbling (Danio rerio, DarT) untersucht. Dieses Testsystem wurde durch Schulte & Nagel (1994) als Alternativmethode zum akuten Fischtest nach OECD 203 entwickelt und bietet den Vorteil neben letalen auch eine Reihe von subletalen Endpunkten erfassen zu können. Es handelt sich zudem nach dem deutschen Tierschutzgesetz nicht um einen Tierversuch. Die generelle Vergleichbarkeit der ermittelten Werte mit Daten aus akuten Fischtests nach OECD 203 sowie die Anwendbarkeit für verschiedenste Fragestellungen konnten in einer Reihe von Studien gezeigt werden (Nagel, 2002). Für die hier vorgestellten Untersuchungen wurden zunächst 32 Pharmaka und drei Pflanzenschutzmittel als Einzelstoffe mit dem DarT untersucht. Basierend auf den Ergebnissen der Einzelstofftests wurden Mischungen sowohl aus Substanzen mit ähnlichen als auch unähnlichen Wirkmechanismen getestet. Es zeigte sich, dass unabhängig vom Wirkmechanismus die Mischungstoxizität durch das Konzept der Konzentrationsadditivität gut vorhergesagt wurde, während das Konzept der Unabhängigen Wirkung die Mischungstoxizität unterschätzte. Ebenfalls konnte gezeigt werden, dass die Kombination der Stoffe auf Basis der NOEC, die im DarT anhand der Herzschlagfrequenz nach 48 Stunden ermittelt wird, zu deutlichen Mischungseffekten führt.