Staff Publications

Staff Publications

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    'Staff publications' is the digital repository of Wageningen University & Research

    'Staff publications' contains references to publications authored by Wageningen University staff from 1976 onward.

    Publications authored by the staff of the Research Institutes are available from 1995 onwards.

    Full text documents are added when available. The database is updated daily and currently holds about 240,000 items, of which 72,000 in open access.

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    A generic PBTK model implemented in the MCRA platform : Predictive performance and uses in risk assessment of chemicals
    Tebby, Cleo ; Voet, Hilko van der; Sousa, Georges de; Rorije, Emiel ; Kumar, Vikas ; Boer, Waldo de; Kruisselbrink, Johannes W. ; Bois, Frédéric Y. ; Faniband, Moosa ; Moretto, Angelo ; Brochot, Céline - \ 2020
    Food and Chemical Toxicology 142 (2020). - ISSN 0278-6915
    Mixtures - Physiologically-based ToxicoKinetic (PBTK) model - Probabilistic model - Risk assessment

    Physiologically-based toxicokinetic (PBTK) models are important tools for in vitro to in vivo or inter-species extrapolations in health risk assessment of foodborne and non-foodborne chemicals. Here we present a generic PBTK model implemented in the EuroMix toolbox, MCRA 9 and predict internal kinetics of nine chemicals (three endocrine disrupters, three liver steatosis inducers, and three developmental toxicants), in data-rich and data-poor conditions, when increasingly complex levels of parametrization are applied. At the first stage, only QSAR models were used to determine substance-specific parameters, then some parameter values were refined by estimates from substance-specific or high-throughput in vitro experiments. At the last stage, elimination or absorption parameters were calibrated based on available in vivo kinetic data. The results illustrate that parametrization plays a capital role in the output of the PBTK model, as it can change how chemicals are prioritized based on internal concentration factors. In data-poor situations, estimates can be far from observed values. In many cases of chronic exposure, the PBTK model can be summarized by an external to internal dose factor, and interspecies concentration factors can be used to perform interspecies extrapolation. We finally discuss the implementation and use of the model in the MCRA risk assessment platform.

    Correction to: Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats
    Steinberg, Pablo ; Voet, Hilko van der; Goedhart, Paul W. ; Kleter, Gijs ; Kok, Esther J. ; Pla, Maria ; Nadal, Anna ; Zeljenková, Dagmar ; Aláčová, Radka ; Babincová, Júlia ; Rollerová, Eva ; Jaďuďová, Soňa ; Kebis, Anton ; Szabova, Elena ; Tulinská, Jana ; Líšková, Aurélia ; Takácsová, Melinda ; Mikušová, Miroslava Lehotská ; Krivošíková, Zora ; Spök, Armin ; Racovita, Monica ; Vriend, Huib de; Alison, Roger ; Alison, Clare ; Baumgärtner, Wolfgang ; Becker, Kathrin ; Lempp, Charlotte ; Schmicke, Marion ; Schrenk, Dieter ; Pöting, Annette ; Schiemann, Joachim ; Wilhelm, Ralf - \ 2020
    Archives of Toxicology 94 (2020). - ISSN 0340-5761 - p. 1779 - 1781.

    In the original publication, the starting point in time for the three feeding trials.

    Natuurinclusieve landbouw: wat mogen we ervan verwachten?
    Melman, T.C.P. - \ 2020
    Vakblad Natuur Bos Landschap 17 (2020)164. - ISSN 1572-7610 - p. 4 - 7.
    De term natuurinclusieve landbouw stamt uit de Rijksvisie Natuurlijk Verder (2014). Het staat voor het verlangen om landbouw en natuur weer bij elkaar te brengen, om landbouw duurzaam te maken. Het begrip is opzettelijk niet strak gedefinieerd omdat het een uitnodiging was om mee te denken hoe de negatieve effecten van landbouw kunnen worden verminderd door meer gebruik te maken van natuur. Met het ecosysteem als basis voor de landbouw zou er wellicht ook meer ruimte komen voor biodiversiteit, was de gedachte. Natuur en landbouw, die vaak op zeer gespannen voet met elkaar staan, zouden zo weer kunnen worden verenigd. Heeft dit kans van slagen of is het idealistische luchtfietserij?
    A retain and refine approach to cumulative risk assessment
    Kennedy, Marc C. ; Hart, Andy D.M. ; Kruisselbrink, Johannes W. ; Lenthe, Marco van; Boer, Waldo J. de; Voet, Hilko van der; Rorije, Emiel ; Sprong, Corinne ; Klaveren, Jacob van - \ 2020
    Food and Chemical Toxicology 138 (2020). - ISSN 0278-6915
    Cumulative assessment group - Mixtures - Pesticides - QSAR - Relative potency factor - Uncertainty

    Mixtures of substances to which humans are exposed may lead to cumulative exposure and health effects. To study their effects, it is first necessary to identify a cumulative assessment group (CAG) of substances for risk assessment or hazard testing. Excluding substances from consideration before there is sufficient evidence may underestimate the risk. Conversely, including everything and treating the inevitable uncertainties using conservative assumptions is inefficient and may overestimate the risk, with an unknown level of protection. An efficient, transparent strategy is described to retain a large group, quantifying the uncertainty of group membership and other uncertainties. Iterative refinement of the CAG then focuses on adding information for the substances with high probability of contributing significantly to the risk. Probabilities can be estimated using expert opinion or derived from data on substance properties. An example is presented with 100 pesticides, in which the retain step identified a single substance to target refinement. Using an updated hazard characterisation for this substance reduced the mean exposure estimate from 0.43 to 0.28 μg kg-bw−1 day−1 and reduced the 99.99th percentile exposure from 24.9 to 5.1 μg kg-bw−1 day−1. Other retained substances contributed little to the risk estimates, even after accounting for uncertainty.

    The MCRA toolbox of models and data to support chemical mixture risk assessment
    Voet, Hilko van der; Kruisselbrink, Johannes W. ; Boer, Waldo J. de; Lenthe, Marco S. van; Heuvel, J.J.B. van den; Crépet, Amélie ; Kennedy, Marc C. ; Zilliacus, Johanna ; Beronius, Anna ; Tebby, Cleo ; Brochot, Céline ; Luckert, Claudia ; Lampen, Alfonso ; Rorije, Emiel ; Sprong, Corinne ; Klaveren, Jacob D. van - \ 2020
    Food and Chemical Toxicology 138 (2020). - ISSN 0278-6915
    Exposure - Hazard - Mixtures - Probabilistic model - Risk assessment - Software

    A model and data toolbox is presented to assess risks from combined exposure to multiple chemicals using probabilistic methods. The Monte Carlo Risk Assessment (MCRA) toolbox, also known as the EuroMix toolbox, has more than 40 modules addressing all areas of risk assessment, and includes a data repository with data collected in the EuroMix project. This paper gives an introduction to the toolbox and illustrates its use with examples from the EuroMix project. The toolbox can be used for hazard identification, hazard characterisation, exposure assessment and risk characterisation. Examples for hazard identification are selection of substances relevant for a specific adverse outcome based on adverse outcome pathways and QSAR models. Examples for hazard characterisation are calculation of benchmark doses and relative potency factors with uncertainty from dose response data, and use of kinetic models to perform in vitro to in vivo extrapolation. Examples for exposure assessment are assessing cumulative exposure at external or internal level, where the latter option is needed when dietary and non-dietary routes have to be aggregated. Finally, risk characterisation is illustrated by calculation and display of the margin of exposure for single substances and for the cumulation, including uncertainties derived from exposure and hazard characterisation estimates.

    Assessment of the combined nitrate and nitrite exposure from food and drinking water: application of uncertainty around the nitrate to nitrite conversion factor
    Brand, Annick D. van den; Beukers, Marja ; Niekerk, Maryse ; Donkersgoed, Gerda van; Aa, Monique van der; Ven, Bianca van de; Bulder, Astrid ; Voet, Hilko van der; Sprong, Corinne R. - \ 2020
    Food Additives & Contaminants. Pt. A, Chemistry, Analysis, Control, Exposure & Risk Assessment 37 (2020)4. - ISSN 1944-0049 - p. 568 - 582.
    conversion factor - drinking water - exposure assessment - food additives - Nitrate - nitrite

    Dietary exposure to nitrate and nitrite occurs via three main sources; occurrence in (vegetable) foods, food additives in certain processed foods and contaminants in drinking water. While nitrate can be converted to nitrite in the human body, their risk assessment is usually based on single substance exposure in different regulatory frameworks. Here, we assessed the long-term combined exposure to nitrate and nitrite from food and drinking water. Dutch monitoring data (2012–2018) and EFSA data from 2017 were used for concentration data. These were combined with data from the Dutch food consumption survey (2012–2016) to assess exposure. A conversion factor (median 0.023; range 0.008–0.07) was used to express the nitrate exposure in nitrite equivalents which was added to the nitrite exposure. The uncertainty around the conversion factor was taken into account by using conversion factors randomly sampled from the abovementioned range. The combined dietary exposure was calculated for the Dutch population (1–79 years) with different exposure scenarios to address regional differences in nitrate and nitrite concentrations in drinking water. All scenarios resulted in a combined exposure above the acceptable daily intake for nitrite ion (70 µg/kg bw), with the mean exposure varying between 95–114 µg nitrite/kg bw/day in the different scenarios. Of all ages, the combined exposure was highest in children aged 1 year with an average of 250 µg nitrite/kg bw/day. Vegetables contributed most to the combined exposure in food in all scenarios, varying from 34%–41%. Food additive use contributed 8%–9% to the exposure and drinking water contributed 3%–19%. Our study is the first to perform a combined dietary exposure assessment of nitrate and nitrite while accounting for the uncertain conversion factor. Such a combined exposure assessment overarching different regulatory frameworks and using different scenarios for drinking water is a better instrument for protecting human health than single substance exposure.

    Statement on advancing the assessment of chemical mixtures and their risks for human health and the environment
    Drakvik, Elina ; Altenburger, Rolf ; Aoki, Yasunobu ; Backhaus, Thomas ; Bahadori, Tina ; Barouki, Robert ; Brack, Werner ; Cronin, Mark T.D. ; Demeneix, Barbara ; Hougaard Bennekou, Susanne ; Klaveren, Jacob van; Kneuer, Carsten ; Kolossa-Gehring, Marike ; Lebret, Erik ; Posthuma, Leo ; Reiber, Lena ; Rider, Cynthia ; Rüegg, Joëlle ; Testa, Giuseppe ; Burg, Bart van der; Voet, Hilko van der; Warhurst, Michael ; Water, Bob van de; Yamazaki, Kunihiko ; Öberg, Mattias ; Bergman, Åke - \ 2020
    Environment International 134 (2020). - ISSN 0160-4120
    Chemical mixtures - Combined exposure - Environmental chemicals - Mixture risk assessment - Risk management

    The number of anthropogenic chemicals, manufactured, by-products, metabolites and abiotically formed transformation products, counts to hundreds of thousands, at present. Thus, humans and wildlife are exposed to complex mixtures, never one chemical at a time and rarely with only one dominating effect. Hence there is an urgent need to develop strategies on how exposure to multiple hazardous chemicals and the combination of their effects can be assessed. A workshop, “Advancing the Assessment of Chemical Mixtures and their Risks for Human Health and the Environment” was organized in May 2018 together with Joint Research Center in Ispra, EU-funded research projects and Commission Services and relevant EU agencies. This forum for researchers and policy-makers was created to discuss and identify gaps in risk assessment and governance of chemical mixtures as well as to discuss state of the art science and future research needs. Based on the presentations and discussions at this workshop we want to bring forward the following Key Messages: • We are at a turning point: multiple exposures and their combined effects require better management to protect public health and the environment from hazardous chemical mixtures. • Regulatory initiatives should be launched to investigate the opportunities for all relevant regulatory frameworks to include prospective mixture risk assessment and consider combined exposures to (real-life) chemical mixtures to humans and wildlife, across sectors. • Precautionary approaches and intermediate measures (e.g. Mixture Assessment Factor) can already be applied, although, definitive mixture risk assessments cannot be routinely conducted due to significant knowledge and data gaps. • A European strategy needs to be set, through stakeholder engagement, for the governance of combined exposure to multiple chemicals and mixtures. The strategy would include research aimed at scientific advancement in mechanistic understanding and modelling techniques, as well as research to address regulatory and policy needs. Without such a clear strategy, specific objectives and common priorities, research, and policies to address mixtures will likely remain scattered and insufficient.

    Validation of the EuroMix model toolbox and comparison with US software : EuroMix Deliverable 7.1
    Lenthe, M.S. van; Boer, W.J. de; Kruisselbrink, J.W. ; Voet, H. van der; Crépét, A. ; Vanacker, Marie ; Trocellier, L. - \ 2019
    EuroMix - 65 p.
    The EuroMix toolbox is a web-based platform including data and models accessible to all key-actors in risk assessment and risk management. The platform includes or links to relevant models to provide estimates of hazard, exposure and risk. The software platform builds on the Monte Carlo Risk Assessment (MCRA) system and is implemented as MCRA version 9.0. MCRA 9.0 is available at https://mcra.rivm.nl.
    MCRA 9.0 is a modular system contains many models for exposure, hazard and risk assessment. Validation of the toolbox as a whole can be broken down into the validation of different parts.
    In this report two types of validation are described, internal and external. Internal validation is concerned with checking the software for programming errors and comparing the functionality and outputs of the models against previously released versions. For internal validation all modules of the toolbox are included.
    External validation compares the functionality and output of the models against external values generated by another existing software platform. Given the wide functionality of the EuroMix toolbox this is a non-trivial task for the toolbox as a whole. In this document external validation is restricted to the aggregation of dietary and nondietary exposures in the Exposures module. This is compared with similar calculations in the US software SHEDS-HT.
    The EuroMix model toolbox MCRA 9 : Deliverable 6.2
    Voet, H. van der; Kruisselbrink, J.W. ; Boer, W.J. de; Lenthe, M.S. van; Heuvel, Hans van den; Crépet, Amélie ; Kennedy, Marc C. ; Zilliacus, Johanna ; Beronius, Anna ; Rorije, Emiel ; Sprong, Corinne ; Klaveren, Jacob van - \ 2019
    EuroMix - 20 p.
    Afval aangetroffen tijdens de jaarlijkse schelpdiermonitoring in de Waddenzee en Nederlandse kustzone in 2019
    Zwol, Jetze van; Troost, Karin - \ 2019
    Yerseke : Wageningen Marine Research (Wageningen Marine Research rapport ; C122/19 ) - 23
    In januari 2019 zijn tijdens een storm zo’n 345 zeecontainers overboord geslagen vanaf containerschip ‘MSC Zoë’. Dit gebeurde in de vaarroute langs de Nederlandse Waddeneilanden in de Noordzee. Een deel van de containers is aangespoeld op de eilanden maar de meeste zijn gezonken. Door de val vanaf het schip zijn containers beschadigd en opengescheurd. Hierbij is veel lading in zee gekomen en als afval naar de eilanden, Waddenzee en de zeebodem verdwenen. De aangespoelde lading is veelal opgeruimd net als de achter gebleven container (resten) op de bodem. Omdat er veel lading achter gebleven is in het marine milieu wordt er verwacht dat dit terug te vinden is tijdens de diverse kust bemonsteringen welke uitgevoerd worden door Wageningen Marine Research (WMR). WMR voert jaarlijkse WOT-schelpdierinventarisaties uit in de Noordzeekustzone en de Waddenzee. Deze surveys bestrijken een groot gebied rond de locatie van het incident en het gebied waar mogelijk afval terecht gekomen is. Deze surveys zijn geselecteerd voor de monitoring van afval dat mogelijk afkomstig zou kunnen zijn uit de lading van de MSC Zoë. Op de Noordzee wordt gebruik gemaakt van een bodemschaaf waarmee op 983 locaties een ‘trek’ van 150 meter gedaan wordt. Op de Waddenzee wordt de bemonstering uitgevoerd met een zuigkor (gesleept), stempelkor en oesterhapper (vast oppervlakte). Door middel van deze tuigen worden 1360 geselecteerde locaties bemonsterd. Daarnaast worden oester- en mosselbanken in kaart gebracht doormiddel van een survey ‘te voet’ waarbij afval verzameld kon worden er is minstens 630 kilometer afgelegd. Op de Noordzee is op 56 locaties afval gevonden, waarschijnlijk is geen enkel soort materiaal afkomstig van de lading van de MSC Zoë. Op de Waddenzee is op 43 locaties afval gevonden tijdens de bemonstering, daarnaast is op 7 verschillende locaties afval aangetroffen tijdens het ‘lopen’. Tijdens de bemonsteringen vanaf het schip is geen materiaal aangetroffen wat gekoppeld kan worden aan de lading van de MSC Zoë. Te voet zijn enkele voorwerpen aangetroffen die waarschijnlijk afkomstig zijn uit de lading van de MSC Zoë. Na de uitvoering van de surveys en analyse van de resultaten lijkt het er op dat de type tuigages welke gebruikt worden voor de bodem bemonstering alleen een klein formaat afval bevatten. Na het incident met de MSC Zoë zijn vooral grotere voorwerpen aangespoeld, die dus in de gebruikte tuigages niet worden teruggevonden. Mogelijk achtergebleven afval lijkt het makkelijkst waar te nemen wanneer de survey te voet plaatsvindt.
    Equivalence Testing Approaches in Genetically Modified Organism Risk Assessment
    Voet, Hilko Van Der; Paoletti, Claudia - \ 2019
    Journal of Agricultural and Food Chemistry 67 (2019)49. - ISSN 0021-8561 - p. 13506 - 13508.
    European Food Safety Authority - genetically modified organism - risk assessment

    Since 2011, the European Food Safety Authority (EFSA) has implemented combined difference and equivalence testing of agronomic, phenotypic, and composition data in the risk assessment of genetically modified crops. A short perspective is provided on misunderstandings that have shown up in published criticisms of the approach to equivalence testing, different viewpoints regarding the questions to be answered, and new developments in statistical modeling.

    Softwaretool voor de blootstelling aan mengsels van pesticide residuen in groenten en fruit : Rapportage project Impactanalyse Pesticiden Groenten en Fruit (IPGF)
    Lenthe, Marco van; Voet, Hilko van der; Meewisse, Astrid - \ 2019
    Wageningen : Wageningen University & Research, Biometris (Wageningen University & Research, Biometris rapport 44) - 41
    Er is een web-portaal gebouwd dat de gebruikers in staat stelt Food Compass monitoring data te combineren met gegevens van de Nederlandse Voedsel Consumptie Peiling volgens moderne probabilistische rekenmethoden conform aanbevelingen van EFSA en het EU project Acropolis. Het cumulatieve risico, dat in eerste instantie vastgesteld wordt op populatieniveau en gebaseerd is op consumptie van alle voedingsmiddelen, wordt vertaald naar een effectieve residubewaking van afzonderlijke partijen groente en fruit zoals wenselijk in de residubewaking van Food Compass
    A probabilistic approach for risk-benefit assessment of food substitutions : A case study on substituting meat by fish
    Thomsen, Sofie Theresa ; Boer, Waldo de; Pires, Sara M. ; Devleesschauwer, Brecht ; Fagt, Sisse ; Andersen, Rikke ; Poulsen, Morten ; Voet, Hilko van der - \ 2019
    Food and Chemical Toxicology 126 (2019). - ISSN 0278-6915 - p. 79 - 96.
    Disability-Adjusted Life Year(DALY) - Food-based dietary guidelines - Health impact - Risk-benefit assessment (RBA) - Substitution - Usual intake difference model

    Accounting for substitution of foods is inevitable when evaluating health impact of dietary changes. But substitution behavior and the associated health impact may vary between individuals. We therefore propose the use of probabilistic methods to model substitution and assess health impact distributions in risk-benefit assessment (RBA) of foods. We investigated the health impact of substituting red and processed meat with fish in the Danish adult population and the variability in health impact. We applied probabilistic approaches in modeling the substitution to reflect variability between individual substitution behaviors. Furthermore, when multiple intake scenarios are compared, we propose a method for adjusting intake differences for individual day-to-day variability. We estimated that 134 (95% UI: 102; 169) Disability-Adjusted Life Years/100,000 were averted per year by the substitution. The health impact varied considerably by age and sex, with the largest health benefit of the substitution observed for young women in the child-bearing age and for the older generation, mainly men. This study provides further insight in how the health impact of substituting meat by fish varies between individuals and suggests a framework to be applied in RBAs of other food substitutions. Our results are relevant for policy makers in defining targeted public health strategies.

    Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats
    Steinberg, Pablo ; Voet, Hilko van der; Goedhart, Paul W. ; Kleter, Gijs ; Kok, Esther J. ; Pla, Maria ; Nadal, Anna ; Zeljenková, Dagmar ; Aláčová, Radka ; Babincová, Júlia ; Rollerová, Eva ; Jaďuďová, Soňa ; Kebis, Anton ; Szabova, Elena ; Tulinská, Jana ; Líšková, Aurélia ; Takácsová, Melinda ; Mikušová, Miroslava Lehotská ; Krivošíková, Zora ; Spök, Armin ; Racovita, Monica ; Vriend, Huib de; Alison, Roger ; Alison, Clare ; Baumgärtner, Wolfgang ; Becker, Kathrin ; Lempp, Charlotte ; Schmicke, Marion ; Schrenk, Dieter ; Pöting, Annette ; Schiemann, Joachim ; Wilhelm, Ralf - \ 2019
    Archives of Toxicology 93 (2019)4. - ISSN 0340-5761 - p. 1095 - 1139.
    Biosafety - Combined chronic toxicity/carcinogenicity study - G-TwYST - Genetically modified maize NK603 - GMO risk assessment - OECD Test Guideline No. 408 - OECD Test Guideline No. 453 - Rat feeding trial - Subchronic oral toxicity study

    In 2012, a controversial study on the long-term toxicity of a Roundup herbicide and the glyphosate-tolerant genetically modified (GM) maize NK603 was published. The EC-funded G-TwYST research consortium tested the potential subchronic and chronic toxicity as well as the carcinogenicity of the glyphosate-resistant genetically modified maize NK603 by performing two 90-day feeding trials, one with GM maize inclusion rates of 11 and 33% and one with inclusion rates of up to 50%, as well as a 2-year feeding trial with inclusion rates of 11 and 33% in male and female Wistar Han RCC rats by taking into account OECD Guidelines for the testing of chemicals and EFSA recommendations on the safety testing of whole-food/feed in laboratory animals. In all three trials, the NK603 maize, untreated and treated once with Roundup during its cultivation, and the conventional counterpart were tested. Differences between each test group and the control group were evaluated. Equivalence was assessed by comparing the observed difference to differences between non-GM reference groups in previous studies. In case of significant differences, whether the effects were dose-related and/or accompanied by changes in related parameters including histopathological findings was evaluated. It is concluded that no adverse effects related to the feeding of the NK603 maize cultivated with or without Roundup for up to 2 years were observed. Based on the outcome of the subchronic and combined chronic toxicity/carcinogenicity studies, recommendations on the scientific justification and added value of long-term feeding trials in the GM plant risk assessment process are presented.

    Equivalence limit scaled differences for untargeted safety assessments : Comparative analyses to guard against unintended effects on the environment or human health of genetically modified maize
    Voet, Hilko van der; Goedhart, Paul W. ; García-Ruiz, Esteban ; Escorial, Concepción ; Tulinská, Jana - \ 2019
    Food and Chemical Toxicology 125 (2019). - ISSN 0278-6915 - p. 540 - 548.
    Arthropods - Equivalence test - Rat feeding study - Risk assessment - Standardised effect size - Unintended effects

    Safety assessments guard against unintended effects for human health and the environment. When new products are compared with accepted reference products by broad arrays of measurements, statistical analyses are usually summarised by significance tests or confidence intervals per endpoint. The traditional approach is to test for statistical significance of differences. However, absence or presence of significant differences is not a statement about safety. Equivalence limits are essential for safety assessment. We propose graphs to present the results of equivalence tests over the array of endpoints. It is argued that plots of the equivalence limit scaled difference (ELSD) are preferable over plots of the standardised effect size (SES) used previously for similar assessments. The ELSD method can be used either with externally specified equivalence limits or with equivalence limits estimated from (historical) data. The method is illustrated with two examples: first, environmental safety of MON810 Bt maize was assessed using field trial count data of arthropods; second, human safety of herbicide tolerant NK603 maize was assessed using haematological, biochemical and organ weight data from a 90-day rat feeding study. All assessed endpoints were classified in EFSA equivalence categories I or II, implying full equivalence or equivalence more likely than not.

    Data from: Equivalence analysis to support environmental safety assessment: using nontarget organism count data from field trials with cisgenically modified potato
    Voet, H. van der; Goedhart, P.W. ; Lazebnik, E. ; Kessel, G.J.T. ; Mullins, Ewen ; Loon, J.J.A. van; Arpaia, Salvatore - \ 2019
    Wageningen University & Research
    This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.
    Equivalence analysis to support environmental safety assessment: Using nontarget organism count data from field trials with cisgenically modified potato
    Voet, Hilko van der; Goedhart, Paul W. ; Lazebnik, Jenny ; Kessel, Geert J.T. ; Mullins, Ewen ; Loon, Joop J.A. van; Arpaia, Salvatore - \ 2019
    Ecology and Evolution 9 (2019)5. - ISSN 2045-7758 - p. 2863 - 2882.
    This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.
    Selecting mixtures on the basis of dietary exposure and hazard data : application to pesticide exposure in the European population in relation to steatosis
    Crépet, Amélie ; Vanacker, Marie ; Sprong, Corinne ; Boer, Waldo de; Blaznik, Urska ; Kennedy, Marc ; Anagnostopoulos, Chris ; Christodoulou, Despo Louca ; Ruprich, Jiří ; Rehurkova, Irena ; Domingo, José Luis ; Hamborg Jensen, Bodil ; Metruccio, Francesca ; Moretto, Angelo ; Jacxsens, Liesbeth ; Spanoghe, Pieter ; Senaeve, David ; Voet, Hilko van der; Klaveren, Jacob van - \ 2019
    International Journal of Hygiene and Environmental Health 222 (2019)2. - ISSN 1438-4639 - p. 291 - 306.
    Cumulative assessment group - Dietary exposure and hazard - Mixture prioritisation - Relative potency factors - Sparse non-negative matrix underestimation

    Populations are exposed to mixtures of pesticides through their diet on a daily basis. The question of which substances should be assessed together remains a major challenge due to the complexity of the mixtures. In addition, the associated risk is difficult to characterise. The EuroMix project (European Test and Risk Assessment Strategies for Mixtures) has developed a strategy for mixture risk assessment. In particular, it has proposed a methodology that combines exposures and hazard information to identify relevant mixtures of chemicals belonging to any cumulative assessment group (CAG) to which the European population is exposed via food. For the purposes of this study, food consumption and pesticide residue data in food and drinking water were obtained from national surveys in nine European countries. Mixtures of pesticides were identified by a sparse non-negative matrix underestimation (SNMU) applied to the specific liver steatosis effect in children from 11 to 15 years of age, and in adults from 18 to 64 years of age in nine European countries. Exposures and mixtures of 144 pesticides were evaluated through four different scenarios: (1) chronic exposure with a merged concentration dataset in the adult population, (2) chronic exposure with country-specific concentration datasets in the adult population, (3) acute exposure with a merged concentration dataset in the adult population, and (4) chronic exposure with a merged concentration dataset in the paediatric population. The relative potency factors of each substance were calculated to express their potency relative to flusilazole, which was chosen as the reference compound. The selection of mixtures and the evaluation of exposures for each country were carried out using the Monte Carlo Risk Assessment (MCRA) software. Concerning chronic exposure, one mixture explained the largest proportion of the total variance for each country, while in acute exposure, several mixtures were often involved. The results showed that there were 15 main pesticides in the mixtures, with a high contribution of imazalil and dithiocarbamate. Since the concentrations provided by the different countries were merged in the scenario using merged concentration data, differences between countries result from differences in food consumption behaviours. These results support the approach that using merged concentration data to estimate exposures in Europe seems to be realistic, as foods are traded across European borders. The originality of the proposed approach was to start from a CAG and to integrate information from combined exposures to identify a refined list of mixtures with fewer components. As this approach was sensitive to the input data and required significant resources, efforts should continue regarding data collection and harmonisation among the different aspects within the pesticides regulatory framework, and to develop methods to group substances and mixtures to characterise the risk.

    Omics analyses of potato plant materials using an improved one-class classification tool to identify aberrant compositional profiles in risk assessment procedures
    Kok, Esther ; Dijk, Jeroen van; Voorhuijzen, Marleen ; Staats, Martijn ; Slot, Martijn ; Lommen, Arjen ; Venema, Dini ; Pla, Maria ; Corujo, Maria ; Barros, Eugenia ; Hutten, Ronald ; Jansen, Jeroen ; Voet, Hilko van der - \ 2019
    Food Chemistry 292 (2019). - ISSN 0308-8146 - p. 350 - 358.
    Compositional analysis - Genetically modified organism - GMO - Omics profiling - Risk assessment

    The objective of this study was to quantitatively assess potato omics profiles of new varieties for meaningful differences from analogous profiles of commercial varieties through the SIMCA one-class classification model. Analytical profiles of nine commercial potato varieties, eleven experimental potato varieties, one GM potato variety that had acquired Phytophtora resistance based on a single insert with potato-derived DNA sequences, and its non-GM commercial counterpart were generated. The ten conventional varieties were used to construct the one-class model. Omics profiles from experimental non-GM and GM varieties were assessed using the one-class SIMCA models. No potential unintended effects were identified in the case of the GM variety. The model showed that varieties that were genetically more distant from the commercial varieties were recognized as aberrant, highlighting its potential in determining whether additional evaluation is required for the risk assessment of materials produced from any breeding technique, including genetic modification.

    Use of omics analytical methods in the study of genetically modified maize varieties tested in 90 days feeding trials
    Corujo, Maria ; Pla, Maria ; Dijk, Jeroen van; Voorhuijzen, Marleen ; Staats, Martijn ; Slot, Martijn ; Lommen, Arjen ; Barros, Eugenia ; Nadal, Anna ; Puigdomènech, Pere ; Paz, José Luís La ; Voet, Hilko van der; Kok, Esther - \ 2019
    Food Chemistry 292 (2019). - ISSN 0308-8146 - p. 359 - 371.
    GMO (genetically modified organism) - Metabolomics - One-class model - Proteomics - Risk assessment - Transcriptomics

    Genetically modified (GM) maize and their non-modified counterparts were compared using MON810 varieties, the only GMO event cultivated in Europe. The differences in grain samples were analysed by omics profiles, including transcriptomics, proteomics and metabolomics. Other cultivated maize varieties were analysed as a reference for the variability that will exist between cultivated varieties. The observed differences between modified and non-modified maize varieties do not exceed typical differences between non-modified varieties. The use of these advanced analytical approaches to analyse novel plant materials as compared to the results from animal feeding trials with whole foods is assessed. No indications were observed for changes in the GM varieties that warrant further investigations. Furthermore, it was shown that such indications will be obtained if maize samples of inferior quality are analysed similarly. Omics data provide detailed analytical information of the plant material, which facilitates a risk assessment procedure of new (GM) plant varieties.

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