Entwicklung eines stufenübergreifenden Qualitätssicherungssystems für die ökologische Ernährungswirtschaft unter besonderer Berücksichtigung der Kommunikations- und Organisationsstrukturen

Im Rahmen des Projektes wurden Konzepte zur Lösung drängender Probleme im Bereich Qualitätssicherung in der Ökologischen Lebensmittelwirtschaft erarbeitet. Dazu wurden Strukturen geschaffen, die es erlaubten die Fachleute der Branche in die Problemanalyse und Lösungserarbeitung einzubeziehen. Durch die intensive Einbindung der Akteure konnte gewährleistet werden, dass die erarbeiteten Konzepte von hoher Relevanz für die Branche und direkt umsetzbar sind. Neben der Erarbeitung von Konzepten war deren Abstimmung mit Branchenvertretern und der Wissenstransfer der Ergebnisse ein Schwerpunkt des Projektes. Die Analyse der Kommunikations- und Organisationsstrukturen der Branche gab Hinweise darauf, welche Akteure von besonderer Relevanz sind, welche Kommunikationsmittel genutzt werden und wo Lücken in den Organisationsstrukturen bestehen. Das Projekt hat im Bereich Kontaminationen von Öko-Lebensmitteln mit Pflanzenschutzmittelrückständen Konzepte erarbeitet, die eine Reduktion der Einträge in Erzeugung und Verarbeitung ermöglichen. Die rechtliche Situation bei Haftungsfragen wurde in leicht verständlicher Form aufgearbeitet. Mit der Kommentierung des Anhang III Nr. 9 der EU-Öko-Verordnung wurden Vorschläge zur effizienten Verbesserung der Kontrollen vorgelegt und Grundlagen geschaffen, um die Auslegung des Gesetzes in EU und Bundesländern zu harmonisieren. Im Bereich Gentechnik wurde ein Konzept zur Verbraucherinformation erarbeitet, welches von den Akteuren der Branche umgesetzt wurde. Erarbeitet wurden weiterhin konkrete Vorschläge für die Weiterentwicklung der gesetzlichen Rahmenbedingungen im Gentechnikbereich, um die Ökologische Lebensmittelwirtschaft in ihrem Bestand zu sichern. Von der angestrebten „Koexistenz“ gehen erhebliche Gefahren für diesen Wirtschaftsbereich aus. Die Erstellung einer „Handlungsempfehlung zur Umsetzung von Maßnahmen der Warenrückverfolgbarkeit und Herkunftssicherung in Unternehmen der Ökologischen Lebensmittelwirtschaft“ ist Hauptergebnis in einem weiteren Bereich des Projekts. Mit dem erarbeiteten Krisenmanagementplan steht der Branche künftig ein Instrument zur Verfügung, den kommunikativen Teil einer Krise koordiniert zu bewältigen

A Phased Approach for preparation and organization of human biomonitoring studies.

Human biomonitoring (HBM) studies like other epidemiological studies are costly and time-consuming. They require the administration of questionnaires and collection of biological samples, putting substantial burden on the participants which may result in low participation rates. The growing importance of HBM studies in epidemiology, exposure assessment and risk assessment underline the importance of optimizing study planning, designing and implementation thus minimizing the above-mentioned difficulties. Based on frameworks from survey design and fieldwork preparation of the European Joint Program HBM4EU, the German Environment Surveys and the COPHES/DEMOCOPHES twin projects combined with elements of project management strategies, a Phased Approach has been developed, introducing a step-by-step guideline for the development of epidemiological studies. The Phased Approach splits the process of developing a study into six phases: Phase 0 (Scoping and Planning): All aspects that are necessary to conduct a study are compiled and put on the agenda for decision-making. Phase 1 (Preparation and Testing): Instruments (e.g. questionnaires), materials (e.g. guidelines, information), and ethics and data management issues, needing thorough preparation and testing before a study can start. Phase 2 (Initiation): Organization and acquisition of necessary equipment and engaging and training personnel. Phase 3 (Implementation): All procedures that require temporal proximity to the start date of fieldwork, such as obtaining contact information of invitees. Phase 4 (Fieldwork and Analysis): Involvement of participants and chemical analysis of the collected samples. Phase 5 (Results and Evaluation): Final procedures leading to closure of the project, such as providing and communicating results. The separation of the planning and conduct of human biomonitoring studies into different phases creates the basis for a structured procedure and facilitates a step-by-step approach reducing costs, warranting high participation rates and increasing quality of conduct. Emphasis is put on a comprehensive scoping phase ensuring high quality of the study design, which is indispensable for reliable results.This document has been created for the HBM4EU project. HBM4EU has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 733032.S

HBM4EU combines and harmonises human biomonitoring data across the EU, building on existing capacity - The HBM4EU survey

As part of the Human Biomonitoring for Europe (HBM4EU) initiative a human biomonitoring (HBM) survey is conducted in 21 countries. This survey builds on existing HBM capacity in Europe by aligning national or regional HBM studies. The survey targets 3 age groups (i) children aged 6-11 years, (ii) teenagers aged 12-19 years and (iii) young adults aged 20-39 years and includes a total of 9493 participants (3151 children, 2953 teenagers and 3389 young adults). Depending on the age group, internal exposure to phthalates and substitute Hexamoll® DINCH, brominated and organophosphorus flame retardants, per-/poly-fluorinated compounds, cadmium, bisphenols and/or polycyclic aromatic hydrocarbons are assessed. The main goal of the programme is to obtain quality controlled and comparable HBM data of exposure to chemicals, prioritized under HBM4EU, with European wide coverage to inform the development of environment and health policies. This paper describes the framework of the HBM4EU survey and the approach that has been applied to align European HBM initiatives across Europe.HBM4EU is co-financed under Horizon 2020 (grant agreement No 733032). The authors thank all principle investigators of the contributing studies for their participation and contribution to the joint HBM4EU survey and the national programme owners for their financial support. In addition we want to thank Dr. Liesbeth Bruckers and Dr. Michael Schümann.S

Challenges to evidence synthesis and identification of data gaps in human biomonitoring

© 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).The increasing number of human biomonitoring (HBM) studies undertaken in recent decades has brought to light the need to harmonise procedures along all phases of the study, including sampling, data collection and analytical methods to allow data comparability. The first steps towards harmonisation are the identification and collation of HBM methodological information of existing studies and data gaps. Systematic literature reviews and meta-analyses have been traditionally put at the top of the hierarchy of evidence, being increasingly applied to map available evidence on health risks linked to exposure to chemicals. However, these methods mainly capture peer-reviewed articles, failing to comprehensively identify other important, unpublished sources of information that are pivotal to gather a complete map of the produced evidence in the area of HBM. Within the framework of the European Human Biomonitoring Initiative (HBM4EU) initiative-a project that joins 30 countries, 29 from Europe plus Israel, the European Environment Agency and the European Commission-a comprehensive work of data triangulation has been made to identify existing HBM studies and data gaps across countries within the consortium. The use of documentary analysis together with an up-to-date platform to fulfil this need and its implications for research and practice are discussed.HBM4EU has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733032.info:eu-repo/semantics/publishedVersio

First steps toward harmonized human biomonitoring in Europe : demonstration project to perform human biomonitoring on a European scale

'Reproduced with permission from Environmental Health Perspectives'Background: For Europe as a whole, data on internal exposure to environmental chemicals do not yet exist. Characterization of the internal individual chemical environment is expected to enhance understanding of the environmental threats to health. Objectives: We developed and applied a harmonized protocol to collect comparable human biomonitoring data all over Europe. Methods: In 17 European countries, we measured mercury in hair and cotinine, phthalate metabolites, and cadmium in urine of 1,844 children (5–11 years of age) and their mothers. Specimens were collected over a 5-month period in 2011–2012. We obtained information on personal characteristics, environment, and lifestyle. We used the resulting database to compare concentrations of exposure biomarkers within Europe, to identify determinants of exposure, and to compare exposure biomarkers with healthbased guidelines. Results: Biomarker concentrations showed a wide variability in the European population. However, levels in children and mothers were highly correlated. Most biomarker concentrations were below the health-based guidance values. Conclusions: We have taken the first steps to assess personal chemical exposures in Europe as a whole. Key success factors were the harmonized protocol development, intensive training and capacity building for field work, chemical analysis and communication, as well as stringent quality control programs for chemical and data analysis. Our project demonstrates the feasibility of a Europe-wide human biomonitoring framework to support the decision-making process of environmental measures to protect public health.The research leading to these results received funding for the COPHES project (COnsortium to Perform Human biomonitoring on a European Scale) from the European Community’s Seventh Framework Programme [FP7/2007–2013] under grant agreement 244237. DEMOCOPHES (DEMOnstration of a study to COordinate and Perform Human biomonitoring on a European Scale) was co-funded (50%:50%) by the European Commission LIFE+ Programme (LIFE09/ENV/BE/000410) and the partners. For information on both projects as well as on the national co-funding institutions, see http://www.eu-hbm.info/. The sponsors had no role in the study design, data collection, data analysis, data interpretation or writing of the report

Outline of a study protocol for combined HBM and health study

This document provides an outline for the study protocol when combining HBM and health studies. When filled-in, the study protocol can also serve as a fieldwork manual even though it will include also sections such as funding which are not relevant for a fieldwork manual. The outline lists the topics which should be covered in the national/regional study protocol. It is highly recommended that feasibility studies conducted under HBM4EU will use this outline to prepare their survey protocol. For feasibility studies, this protocol and its annexes are needed in English to facilitate evaluation. As an exception, official documents such as ethical approval documents that may be available only in a national language, can be provided in the national language and described in English. In possible further national studies, the protocol can be prepared in national languages

Human biomonitoring as a tool to support chemicals regulation in the European Union

Human biomonitoring as a tool to support chemicals regulation in the European Union Discussio

A step towards harmonising human biomonitoring study setup on European level: Materials provided and lessons learnt in HBM4EU.

Internal exposure of the human body to potentially harmful chemical substances can be assessed by Human Biomonitoring (HBM). HBM can be used to generate conclusive data that may provide an overview of exposure levels in entire or specific population groups. This knowledge can promote the understanding of potential risks of the substances of interest or help monitoring the success of regulatory measures taken on the political level. Study planning and design are key elements of any epidemiologic study to generate reliable data. In the field of HBM, this has been done using differing approaches on various levels of population coverage so far. Comparison and combined usage of the resulting data would contribute to understanding exposure and its factors on a larger scale, however, the differences between studies make this a challenging and somewhat limited endeavour. This article presents templates for documents that are required to set up an HBM study, thus facilitating the generation of harmonised HBM data as a step towards standardisation of HBM in Europe. They are designed to be modular and adaptable to the specific needs of a single study while emphasising minimum requirements to ensure comparability. It further elaborates on the challenges encountered during the process of creating these documents during the runtime of the European Joint Programme HBM4EU in a multi-national expert team and draws up lessons learnt in the context of knowledge management.This report was developed under the Horizon 2020 project HBM4EU (WP7 “Survey design and fieldwork preparation”) (www.hbm4eu.eu). HBM4EU has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 733032. This article reflects only the authors’ view and the European Commission is not responsible for any use that may be made of the information it contains. The authors would like to express their gratitude towards all partners participating in WP7, to wards the HBM4EU Chemical Group Leaders who have contributed with their valuable experiences and expertise to the creation of the described documents as well as towards the cofunding national authorities.S