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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    Trawl fishing impacts on the status of seabed fauna in diverse regions of the globe
    Mazor, Tessa ; Pitcher, C.R. ; Rochester, Wayne ; Kaiser, Michel J. ; Hiddink, Jan G. ; Jennings, Simon ; Amoroso, Ricardo ; McConnaughey, Robert A. ; Rijnsdorp, Adriaan D. ; Parma, Ana M. ; Suuronen, Petri ; Collie, Jeremy ; Sciberras, Marija ; Atkinson, Lara ; Durholtz, Deon ; Ellis, Jim R. ; Bolam, Stefan G. ; Schratzberger, Michaela ; Couce, Elena ; Eggleton, Jacqueline ; Garcia, Clement ; Kainge, Paulus ; Paulus, Sarah ; Kathena, Johannes N. ; Gogina, Mayya ; Denderen, P.D. van; Keller, Aimee A. ; Horness, Beth H. ; Hilborn, Ray - \ 2020
    Fish and Fisheries (2020). - ISSN 1467-2960
    benthic invertebrates - ecosystem-based fisheries management - risk assessment - species distribution modelling - sustainable fisheries - trawling

    Bottom trawl fishing is a controversial activity. It yields about a quarter of the world's wild seafood, but also has impacts on the marine environment. Recent advances have quantified and improved understanding of large-scale impacts of trawling on the seabed. However, such information needs to be coupled with distributions of benthic invertebrates (benthos) to assess whether these populations are being sustained under current trawling regimes. This study collated data from 13 diverse regions of the globe spanning four continents. Within each region, we combined trawl intensity distributions and predicted abundance distributions of benthos groups with impact and recovery parameters for taxonomic classes in a risk assessment model to estimate benthos status. The exposure of 220 predicted benthos-group distributions to trawling intensity (as swept area ratio) ranged between 0% and 210% (mean = 37%) of abundance. However, benthos status, an indicator of the depleted abundance under chronic trawling pressure as a proportion of untrawled state, ranged between 0.86 and 1 (mean = 0.99), with 78% of benthos groups > 0.95. Mean benthos status was lowest in regions of Europe and Africa, and for taxonomic classes Bivalvia and Gastropoda. Our results demonstrate that while spatial overlap studies can help infer general patterns of potential risk, actual risks cannot be evaluated without using an assessment model that incorporates trawl impact and recovery metrics. These quantitative outputs are essential for sustainability assessments, and together with reference points and thresholds, can help managers ensure use of the marine environment is sustainable under the ecosystem approach to management.

    Application of the Safe-by-Design Concept in Crop Breeding Innovation
    Berg, Jan Pieter van der; Kleter, G.A. ; Battaglia, E. ; Bouwman, L.M.S. ; Kok, E.J. - \ 2020
    International Journal of Environmental Research and Public Health 17 (2020)17. - ISSN 1660-4601 - 14 p.
    crop breeding innovations - food - risk assessment - safe-by-design - synthetic biology
    The present paper proposes the application of the safe-by-design concept to crop breeding innovation with the aim to accommodate safety considerations for new agricultural food and feed products. Safe-by-design can be implemented in all stages of the innovation cycle of agricultural products, from the early stages of research and development towards the post-market stage. Our proposed application of safe-by-design can be part of “responsible research and innovation” concepts, because they share features such as risk prevention strategies and a participatory approach. Early awareness of potential safety issues can guide the development of agricultural products towards safe options, both at the process and product level, and thus may help to reduce extensive pre-market assessment studies that might otherwise be needed further downstream for regulatory product approval. Here, it is discussed how the proposed safe-by-design approach can be introduced into the development of safe food crops using emerging technologies, such as gene editing and synthetic biology, and how this may help to safeguard the safety of our food and feed supply in the light of the ongoing global innovations in agricultural crop breeding.
    Possible effects of titanium dioxide particles on human liver, intestinal tissue, spleen and kidney after oral exposure
    Brand, Walter ; Peters, Ruud J.B. ; Braakhuis, Hedwig M. ; Maślankiewicz, Lidka ; Oomen, Agnes G. - \ 2020
    Nanotoxicology 14 (2020)7. - ISSN 1743-5390 - p. 985 - 1007.
    Adverse Outcome Pathway (AOP) - food additive E171 - internal organ concentration - risk assessment - TiO2

    Recent studies reported adverse liver effects and intestinal tumor formation after oral exposure to titanium dioxide (TiO2). Other oral toxicological studies, however, observed no effects on liver and intestine, despite prolonged exposure and/or high doses. In the present assessment, we aimed to better understand whether TiO2 can induce such effects at conditions relevant for humans. Therefore, we focused not only on the clinical and histopathological observations, but also used Adverse Outcome Pathways (AOPs) to consider earlier steps (Key Events). In addition, aiming for a more accurate risk assessment, the available information on organ concentrations of Ti (resulting from exposure to TiO2) from oral animal studies was compared to recently reported concentrations found in human postmortem organs. The overview obtained with the AOP approach indicates that TiO2 can trigger a number of key events in liver and intestine: Reactive Oxygen Species (ROS) generation, induction of oxidative stress and inflammation. TiO2 seems to be able to exert these early effects in animal studies at Ti liver concentrations that are only a factor of 30 and 6 times higher than the median and highest liver concentration found in humans, respectively. This confirms earlier conclusions that adverse effects on the liver in humans as a result of (oral) TiO2 exposure cannot be excluded. Data for comparison with Ti levels in human intestinal tissue, spleen and kidney with effect concentrations were too limited to draw firm conclusions. The Ti levels, though, are similar or higher than those found in liver, suggesting these tissues may be relevant too.

    The safety evaluation of food flavoring substances : the role of genotoxicity studies
    Gooderham, Nigel J. ; Cohen, Samuel M. ; Eisenbrand, Gerhard ; Fukushima, Shoji ; Guengerich, F.P. ; Hecht, Stephen S. ; Rietjens, Ivonne M.C.M. ; Rosol, Thomas J. ; Bastaki, Maria ; Linman, Matthew J. ; Taylor, Sean V. - \ 2020
    Critical Reviews in Toxicology 50 (2020)1. - ISSN 1040-8444 - p. 1 - 27.
    chromosomal damage - DNA adducts - FEMA GRAS - flavoring substance - flavors - genotoxicity - mutagenicity - risk assessment - safety assessment - weight of evidence

    The Flavor and Extract Manufacturers Association (FEMA) Expert Panel relies on the weight of evidence from all available data in the safety evaluation of flavoring substances. This process includes data from genotoxicity studies designed to assess the potential of a chemical agent to react with DNA or otherwise cause changes to DNA, either in vitro or in vivo. The Panel has reviewed a large number of in vitro and in vivo genotoxicity studies during the course of its ongoing safety evaluations of flavorings. The adherence of genotoxicity studies to standardized protocols and guidelines, the biological relevance of the results from those studies, and the human relevance of these studies are all important considerations in assessing whether the results raise specific concerns for genotoxic potential. The Panel evaluates genotoxicity studies not only for evidence of genotoxicity hazard, but also for the probability of risk to the consumer in the context of exposure from their use as flavoring substances. The majority of flavoring substances have given no indication of genotoxic potential in studies evaluated by the FEMA Expert Panel. Examples illustrating the assessment of genotoxicity data for flavoring substances and the consideration of the factors noted above are provided. The weight of evidence approach adopted by the FEMA Expert Panel leads to a rational assessment of risk associated with consumer intake of flavoring substances under the conditions of use.

    Cross-Validation of Generic Risk Assessment Tools for Animal Disease Incursion Based on a Case Study for African Swine Fever
    Vos, Clazien J. de; Taylor, Rachel A. ; Simons, Robin R.L. ; Roberts, Helen ; Hultén, Cecilia ; Koeijer, Aline A. de; Lyytikäinen, Tapani ; Napp, Sebastian ; Boklund, Anette ; Petie, Ronald ; Sörén, Kaisa ; Swanenburg, Manon ; Comin, Arianna ; Seppä-Lassila, Leena ; Cabral, Maria ; Snary, Emma L. - \ 2020
    Frontiers in Veterinary Science 7 (2020). - ISSN 2297-1769
    African swine fever - cross-validation - generic model - introduction risk - livestock diseases - model uncertainty - risk assessment

    In recent years, several generic risk assessment (RA) tools have been developed that can be applied to assess the incursion risk of multiple infectious animal diseases allowing for a rapid response to a variety of newly emerging or re-emerging diseases. Although these tools were originally developed for different purposes, they can be used to answer similar or even identical risk questions. To explore the opportunities for cross-validation, seven generic RA tools were used to assess the incursion risk of African swine fever (ASF) to the Netherlands and Finland for the 2017 situation and for two hypothetical scenarios in which ASF cases were reported in wild boar and/or domestic pigs in Germany. The generic tools ranged from qualitative risk assessment tools to stochastic spatial risk models but were all parameterized using the same global databases for disease occurrence and trade in live animals and animal products. A comparison of absolute results was not possible, because output parameters represented different endpoints, varied from qualitative probability levels to quantitative numbers, and were expressed in different units. Therefore, relative risks across countries and scenarios were calculated for each tool, for the three pathways most in common (trade in live animals, trade in animal products, and wild boar movements) and compared. For the 2017 situation, all tools evaluated the risk to the Netherlands to be higher than Finland for the live animal trade pathway, the risk to Finland the same or higher as the Netherlands for the wild boar pathway, while the tools were inconclusive on the animal products pathway. All tools agreed that the hypothetical presence of ASF in Germany increased the risk to the Netherlands, but not to Finland. The ultimate aim of generic RA tools is to provide risk-based evidence to support risk managers in making informed decisions to mitigate the incursion risk of infectious animal diseases. The case study illustrated that conclusions on the ASF risk were similar across the generic RA tools, despite differences observed in calculated risks. Hence, it was concluded that the cross-validation contributed to the credibility of their results.

    Options to Reform the European Union Legislation on GMOs: Risk Governance
    Eriksson, Dennis ; Custers, René ; Edvardsson Björnberg, Karin ; Hansson, Sven Ove ; Purnhagen, Kai ; Qaim, Matin ; Romeis, Jörg ; Schiemann, Joachim ; Schleissing, Stephan ; Tosun, Jale ; Visser, Richard G.F. - \ 2020
    Trends in Biotechnology 38 (2020)4. - ISSN 0167-7799 - p. 349 - 351.
    EU - GMO - legislative reform - risk assessment - risk management

    Here, we discuss options to reform the EU genetically modified organism (GMO) regulatory framework, to make risk assessment and decision-making more consistent with scientific principles, and to lay the groundwork for international coherence. We discussed the scope and definitions in a previous article and, thus, here we focus on the procedures for risk assessment and risk management.

    Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels
    Schrenk, Dieter ; Bignami, Margherita ; Bodin, Laurent ; Chipman, James Kevin ; Mazo, Jesús del; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Hoogenboom, Laurentius ; Leblanc, Jean Charles ; Nebbia, Carlo Stefano ; Nielsen, Elsa ; Ntzani, Evangelia ; Petersen, Annette ; Sand, Salomon ; Vleminckx, Christiane ; Wallace, Heather ; Benford, Diane ; Brimer, Leon ; Mancini, Francesca Romana ; Metzler, Manfred ; Viviani, Barbara ; Altieri, Andrea ; Arcella, Davide ; Steinkellner, Hans ; Schwerdtle, Tanja - \ 2019
    EFSA Journal 17 (2019)4. - ISSN 1831-4732
    cyanide - cyanogenic glycosides - health-based guidance values - risk assessment

    In 2016, the EFSA Panel on Contaminants in the Food Chain (CONTAM) published a scientific opinion on the acute health risks related to the presence of cyanogenic glycosides (CNGs) in raw apricot kernels in which an acute reference dose (ARfD) of 20 μg/kg body weight (bw) was established for cyanide (CN). In the present opinion, the CONTAM Panel concluded that this ARfD is applicable for acute effects of CN regardless the dietary source. To account for differences in cyanide bioavailability after ingestion of certain food items, specific factors were used. Estimated mean acute dietary exposures to cyanide from foods containing CNGs did not exceed the ARfD in any age group. At the 95th percentile, the ARfD was exceeded up to about 2.5-fold in some surveys for children and adolescent age groups. The main contributors to exposures were biscuits, juice or nectar and pastries and cakes that could potentially contain CNGs. Taking into account the conservatism in the exposure assessment and in derivation of the ARfD, it is unlikely that this estimated exceedance would result in adverse effects. The limited data from animal and human studies do not allow the derivation of a chronic health-based guidance value (HBGV) for cyanide, and thus, chronic risks could not be assessed.

    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.

    The Evolution and Cultural Framing of Food Safety Management Systems—Where From and Where Next?
    Manning, Louise ; Luning, Pieternel A. ; Wallace, Carol A. - \ 2019
    Comprehensive Reviews in Food Science and Food Safety 18 (2019)6. - ISSN 1541-4337 - p. 1770 - 1792.
    food safety - food safety culture - HACCP - private food safety and quality standards - risk assessment

    The aim of this paper is to review the development of food safety management systems (FSMS) from their origins in the 1950s to the present. The food safety challenges in modern food supply systems are explored and it is argued that there is a need for a more holistic thinking approach to food safety management. The narrative review highlights that while the transactional elements of how FSMS are developed, validated, implemented, monitored, and verified remains largely unchanged, how organizational culture frames the operation and efficacy of FSMS is becoming more important. The evolution of a wider academic and industry understanding of both the influence of food safety culture (FS-culture) and also how such culture frames and enables, or conversely restricts the efficacy of the FSMS is crucial for consumer well-being. Potential research gaps worthy of further study are identified as well as recommendations given for the application of the research findings within the food industry.

    Comparison of Pesticide Exposure in Honey Bees (Hymenoptera : Apidae) and Bumble Bees (Hymenoptera: Apidae): Implications for Risk Assessments
    Gradish, Angela E. ; Steen, Jozef Van Der; Scott-Dupree, Cynthia D. ; Cabrera, Ana R. ; Cutler, G.C. ; Goulson, Dave ; Klein, Olaf ; Lehmann, David M. ; Lückmann, Johannes ; O'Neill, Bridget ; Raine, Nigel E. ; Sharma, Bibek ; Thompson, Helen - \ 2019
    Environmental Entomology 48 (2019)1. - ISSN 0046-225X - p. 12 - 21.
    bumble bee - honey bee - pesticide exposure - risk assessment

    To date, regulatory pesticide risk assessments have relied on the honey bee (Apis mellifera L.) (Hymenoptera: Apidae) as a surrogate test species for estimating the risk of pesticide exposure to all bee species. However, honey bees and non-Apis bees may differ in their susceptibility and exposure to pesticides. In 2017, a workshop ('Pesticide Exposure Assessment Paradigm for Non-Apis Bees') was held to assess if honey bee risk assessment frameworks are reflective of non-Apis bee pesticide exposure. In this article, we summarize the workshop discussions on bumble bees (Bombus spp.). We review the life history and foraging behavior of bumble bees and honey bees and discuss how these traits may influence routes and levels of exposure for both taxa. Overall, the major pesticide exposure routes for bumble bees and honey bees are similar; however, bumble bees face additional exposure routes (direct exposure of foraging queens and exposure of larvae and adults to soil residues). Furthermore, bumble bees may receive comparatively higher pesticide doses via contact or oral exposure. We conclude that honey bee pesticide risk assessments may not always be protective of bumble bees, especially queens, in terms of exposure. Data needed to reliably quantify pesticide exposure for bumble bees (e.g., food consumption rates, soil residue levels) are lacking. Addressing these knowledge gaps will be crucial before bumble bee exposure can be incorporated into the pesticide risk assessment process. Because bumble bees exhibit appreciable interspecific variation in colony and behavioral characteristics, data relevant to pesticide exposure should be generated for multiple species.

    Gene-Edited Crops : Towards a Harmonized Safety Assessment
    Kleter, Gijs A. ; Kuiper, Harry A. ; Kok, Esther J. - \ 2019
    Trends in Biotechnology 37 (2019)5. - ISSN 0167-7799 - p. 443 - 447.
    crop biotechnology - gene editing - genetically modified crops - international harmonization - novel plant breeding techniques - regulation - risk assessment - safety assessment

    Gene editing and other innovative plant breeding techniques are transforming the field of crop biotechnology. Divergent national regulatory regimes worldwide apply to crops bred with these techniques. A plea is made for international harmonization of the premarket assessment of their safety. Such harmonization has previously been achieved for genetically modified (GM) crops.

    A systematic knowledge synthesis on the spatial dimensions of Q fever epidemics
    Rooij, Myrna M.T. de; Leuken, Jeroen P.G. van; Swart, Arno ; Kretzschmar, Mirjam E.E. ; Nielen, Mirjam ; Koeijer, Aline A. de; Janse, Ingmar ; Wouters, Inge M. ; Heederik, Dick J.J. - \ 2019
    Zoonoses and Public Health 66 (2019)1. - ISSN 1863-1959 - p. 14 - 25.
    airborne exposure - Coxiella burnetii - epidemiology - Q fever - risk assessment - spatial analysis

    From 2007 through 2010, the Netherlands experienced the largest Q fever epidemic ever reported. This study integrates the outcomes of a multidisciplinary research programme on spatial airborne transmission of Coxiella burnetii and reflects these outcomes in relation to other scientific Q fever studies worldwide. We have identified lessons learned and remaining knowledge gaps. This synthesis was structured according to the four steps of quantitative microbial risk assessment (QMRA): (a) Rapid source identification was improved by newly developed techniques using mathematical disease modelling; (b) source characterization efforts improved knowledge but did not provide accurate C. burnetii emission patterns; (c) ambient air sampling, dispersion and spatial modelling promoted exposure assessment; and (d) risk characterization was enabled by applying refined dose–response analyses. The results may support proper and timely risk assessment and risk management during future outbreaks, provided that accurate and structured data are available and exchanged readily between responsible actors.

    Investigating the variance of edge-of-field deposits of spray drift
    Holterman, H.J. ; Michielsen, J.M.G.P. ; Stallinga, H. ; Velde, P. van; Zande, J.C. van de - \ 2018
    pesticide - statistics - risk assessment - systems analysis
    Spray applications in arable crops often lead to off-target spray deposits downwind from the treated field. Throughout several decades, many experiments have been carried out by different researchers to quantify the downwind spray deposits. Relations between downwind spray deposits and parameters like sprayer settings, field conditions and environmental conditions were investigated. Still, there is a large variance in the observed data that cannot be explained satisfactorily by the experimental and environmental conditions. Sprayer boom movements and local fluctuations in driving speed, wind speed and wind direction are the most likely factors affecting variance in downwind spray deposits.
    In this study variations in downwind deposits of spray drift caused by sprayer boom movements are investigated both experimentally and based on simulations using the spray drift model IDEFICS. Downwind deposits of spray drift were measured alongside a treated potato field, at 2 m and 5 m off the edge. Wind speed and direction were recorded during the experiments. Horizontal and vertical movements of the sprayer boom were recorded as well. Variance of spray deposits at 2 m downwind from the field edge was about 50%. At 5 m downwind variance was about 30%.
    A quasi-dynamic model was developed based on the IDEFICS spray drift model. In the new model the effect of both horizontal and vertical boom movements on downwind spray deposits was studied. From the above mentioned experiments, the most important frequencies and amplitudes of boom movements were derived. Using these frequencies, the model simulations resulted in variances of spray drift deposits similar to those established experimentally. Effects of fluctuating wind directions are to be investigated in the near future.
    Exposure assessment for edge-of-field watercourses next to tree nurseries regarding spray drift deposits
    Holterman, H.J. ; Zande, J.C. van de - \ 2018
    pesticide - statistics - risk assessment - systems analysis - risk assessment - pesticide - surface water - spatial
    Spray applications in arable crops often lead to off-target spray deposits downwind from the treated field. Throughout several decades, many experiments have been carried out by different researchers to quantify the downwind spray deposits. Relations between downwind spray deposits and parameters like sprayer settings, field conditions and environmental conditions were investigated. Still, there is a large variance in the observed data that cannot be explained satisfactorily by the experimental and environmental conditions. Sprayer boom movements and local fluctuations in driving speed, wind speed and wind direction are the most likely factors affecting variance in downwind spray deposits.
    In this study variations in downwind deposits of spray drift caused by sprayer boom movements are investigated both experimentally and based on simulations using the spray drift model IDEFICS. Downwind deposits of spray drift were measured alongside a treated potato field, at 2 m and 5 m off the edge. Wind speed and direction were recorded during the experiments. Horizontal and vertical movements of the sprayer boom were recorded as well. Variance of spray deposits at 2 m downwind from the field edge was about 50%. At 5 m downwind variance was about 30%.
    A quasi-dynamic model was developed based on the IDEFICS spray drift model. In the new model the effect of both horizontal and vertical boom movements on downwind spray deposits was studied. From the above mentioned experiments, the most important frequencies and amplitudes of boom movements were derived. Using these frequencies, the model simulations resulted in variances of spray drift deposits similar to those established experimentally. Effects of fluctuating wind directions are to be investigated in the near future.
    UV-filters and musk fragrances in seafood commercialized in Europe Union: Occurrence, risk and exposure assessment
    Cunha, S.C. ; Trabalón, L. ; Jacobs, S. ; Castro, M. ; Fernandez-Tejedor, M. ; Granby, K. ; Verbeke, W. ; Kwadijk, C. ; Ferrari, F. ; Robbens, J. ; Sioen, I. ; Pocurull, E. ; Marques, A. ; Fernandes, J.O. ; Domingo, J.L. - \ 2018
    Environmental Research 161 (2018). - ISSN 0013-9351 - p. 399 - 408.
    fish - UV-filters - Musk fragrances - Occurrence - risk assessment - GC-MS/MS
    In the framework of the FP7 ECsafeSeafood project, 62 seafood samples commercialized in Europe Union from several representative species – mackerel, tuna, salmon, seabream, cod, monkfish, crab, shrimp, octopus, perch
    and plaice – were analysed for residues of 21 personal care products (PCPs), including 11 UV-filters (UV-Fs) and 10 musk fragrances (musks). PCPs analysis were performed by Quick, Easy, Cheap, Effective Rugged, Safe (QuEChERS), combined with liquid-liquid extraction (LLE) or dispersive solid-phase extraction (dSPE), followed by gas chromatography-tandem mass spectrometry (GC-MS/MS). The results showed the presence in a wide range of samples of nine out of eleven UV-Fs compounds analysed, namely 2-ethylhexyl salicylate (EHS), 2-
    ethylhexyl,4-methoxycinnamate (EHMC), 4-methylbenzylidenecamphor (4-MBC), benzophenone-1 (BP1), benzophenone- 3 (BP3), isoamyl-4-methoxycinnamate (IMC), 2,2′-dihydroxy-4,4′-dimethoxybenzophenone (DHMB), homosalate (HS), and octocrylene (OC), whereas galaxolide (HHCB), galaxolide lactone (HHCB-lactone), and tonalide (AHTN) were the most found musks. The potential risks to human health associated with the exposure to eight of the more prevalent PCPs – EHS, EHMC, 4-MBC, BP1, BP3, IMC, HHCB, and AHTN - through seafood
    consumption were assessed for consumers from five European countries (Belgium, Ireland, Italy, Portugal and Spain). Results showed that the human exposure to UV-Fs and musks estimated from the concentration values
    found in seafood and the daily consumption of concerned seafood species, were far below toxicological reference values.
    Application of Bayesian networks for hazard ranking of nanomaterials to support human health risk assessment
    Marvin, H.J.P. ; Bouzembrak, Y. ; Janssen, E.M. ; Zande, M. van der; Murphy, Finbarr ; Sheehan, Barry ; Mullins, Martin ; Bouwmeester, H. - \ 2017
    Wageningen University & Research
    Bayesian networks - metal nanomaterials - scenario studies - risk assessment - expert elicitation
    In this study, a Bayesian Network (BN) was developed for the prediction of the hazard potential and biological effects with the focus on metal- and metal-oxide nanomaterials to support human health risk assessment. The developed BN captures the (inter) relationships between the exposure route, the nanomaterials physicochemical properties and the ultimate biological effects in a holistic manner and was based on international expert consultation and the scientific literature (e.g., in vitro/in vivo data). The BN was validated with independent data extracted from published studies and the accuracy of the prediction of the nanomaterials hazard potential was 72% and for the biological effect 71%, respectively. The application of the BN is shown with scenario studies for TiO2, SiO2, Ag, CeO2, ZnO nanomaterials. It is demonstrated that the BN may be used by different stakeholders at several stages in the risk assessment to predict certain properties of a nanomaterials of which little information is available or to prioritize nanomaterials for further screening.
    The Regulatory Framework Across International Jurisdictions for Risks Associated with Consumption of Botanical Food Supplements
    Low, Teng Yong ; Wong, Kwok Onn ; Yap, Adelene L.L. ; Haan, Laura H.J. De; Rietjens, Ivonne M.C.M. - \ 2017
    Comprehensive Reviews in Food Science and Food Safety 16 (2017)5. - ISSN 1541-4337 - p. 821 - 834.
    botanical food supplements - botanicals - regulatory challenges - regulatory framework - risk assessment

    Dietary supplements, including those containing botanical ingredients and botanical-derived compounds, have been marketed to consumers globally for many decades. However, the legislative framework for such products remains inconsistent across jurisdictions internationally. This study aims to compare the regulatory framework of botanical food supplements in the EU, USA, Canada, Australia, New Zealand, India, Japan, and China. The study also aims to investigate and describe safety assessment criteria for botanical food supplements where they are present in the above said jurisdictions, and attempts to analyze whether these criteria are suitable for addressing the toxicological risks associated with the use of botanical food supplement products, based on the evaluation of reported adverse effects related to botanical food supplement use as examples. Finally, this study discusses some future issues that need further attention, such as the consideration of less than lifetime exposures, potential for misidentification, and adulteration of botanical supplements by pharmacologically active substances. It is concluded that the regulatory approaches towards botanical food supplements differ significantly across jurisdictions. In addition, national authorities are increasingly considering having more regulatory oversight for such products. Further consideration of the actual impact of adverse events arising from botanical food supplement usage will be helpful in guiding such decisions.

    Risk assessment of combined exposure to alkenylbenzenes through consumption of plant food supplements containing parsley and dill
    Alajlouni, Abdalmajeed M. ; Al-Malahmeh, Amer J. ; Wesseling, Sebastiaan ; Kalli, Marina ; Vervoort, Jacques ; Rietjens, Ivonne M.C.M. - \ 2017
    Food Additives & Contaminants. Pt. A, Chemistry, Analysis, Control, Exposure & Risk Assessment 34 (2017)12. - ISSN 1944-0049 - p. 2201 - 2211.
    alkenylbenzenes - estimated daily intake - margin of exposure - Parsley- and dill-based plant food supplements (PFS) - risk assessment - toxic equivalency approach
    A risk assessment was performed of parsley- and dill-based plant food supplements (PFS) containing apiol and related alkenylbenzenes. First, the levels of the alkenylbenzenes in the PFS and the resulting estimated daily intake (EDI) resulting from use of the PFS were quantified. Since most PFS appeared to contain more than one alkenylbenzene, a combined risk assessment was performed based on equal potency or using a so-called toxic equivalency (TEQ) approach based on toxic equivalency factors (TEFs) for the different alkenylbenzenes. The EDIs resulting from daily PFS consumption amount to 0.74–125 µg kg–1 bw for the individual alkenylbenzenes, 0.74–160 µg kg–1 bw for the sum of the alkenylbenzenes, and 0.47–64 µg kg–1 bw for the sum of alkenylbenzenes when expressed in safrole equivalents. The margins of exposure (MOEs) obtained were generally below 10,000, indicating a priority for risk management if the PFS were to be consumed on a daily basis. Considering short-term use of the PFS, MOEs would increase above 10,000, indicating low priority for risk management. It is concluded that alkenylbenzene intake through consumption of parsley- and dill-based PFS is only of concern when these PFS are used for long periods of time.
    Potatoes, pathogens and pests : effects of genetic modifi cation for plant resistance on non-target arthropods
    Lazebnik, Jenny - \ 2017
    Wageningen University. Promotor(en): J.J.A. Loon; M. Dicke. - Wageningen : Wageningen University - ISBN 9789463431620 - 151
    solanum tuberosum - potatoes - oomycetes - phytophthora infestans - genetic engineering - transgenic plants - disease resistance - risk assessment - nontarget organisms - arthropods - insect pests - herbivores - trophic levels - ecological risk assessment - greenhouse experiments - field experimentation - solanum tuberosum - aardappelen - oömyceten - phytophthora infestans - genetische modificatie - transgene planten - ziekteresistentie - risicoschatting - niet-doelorganismen - geleedpotigen - insectenplagen - herbivoren - trofische graden - ecologische risicoschatting - kasproeven - experimenteel veldonderzoek

    Currently, fungicides are necessary to protect potato crops against late blight, Phytophthora infestans, one of the world’s most damaging crop pathogens. The introgression of plant resistance genes from wild potato species targeted specifically to the late blight pathogen into susceptible potato varieties may alleviate the environmental impact of chemical control. Genetically modified plants are subject to an environmental risk assessment, and this includes testing for risks to the non-target arthropod community associated with the crop. The thesis begins with a review about the main plant defense responses and their role in influencing sequential interactions between herbivores and plant pathogens. The experimental chapters each focus on different aspects of the interaction between potato plants (both resistant and susceptible), the target pathogen (P. infestans) and several non-target insects. With each chapter, the scope widens: from the molecular gene expression in potato leaves in response to sequential attacks, to field scale biodiversity analyses. At the molecular level, one of the main findings was that the genomic position of the Rpi-vnt1 insertion conferring resistance to P. infestans influenced potato gene expression measured in leaves, when interacting with the non-target insect pests Myzus persicae (Green peach aphid) and Leptinotarsa decemlineata (Colorado potato beetle). Insect performance differed between the resistant GM and susceptible non-GM comparator. In the following chapter, the differences in insect performance were tested across a range of conventionally bred cultivars varying in resistance to P. infestans. Differences in M. persicae performance between several cultivars greatly outweighed the differences previously detected between the GM and non-GM comparator. These results are crucial in shaping the way risk is assessed in the context of GM crops, and these results are supported in our experiments assessing effects on biodiversity with pitfall traps in the field. The third trophic level was also addressed by comparing the performance of the parasitoid Aphidius colemani reared on GM and non-GM fed aphids, both with an without exposure to P. infestans. Differences in parasitoid performance were only found on the susceptible cultivar when inoculated with P. infestans. In the last experimental chapter the risk assessment is taken to the field comparing pitfall trap catches over two years and in two countries. Different methods for statistical analysis of biodiversity data were compared to arrive at recommendations for such analysis in the framework of environmental risk assessments. Drawing on these lessons, the discussion ends with ideas for the development of protocols for environmental risk assessments in the light of expected scientific progress in agricultural biotechnology.

    Integrated strategy for the assessment of kidney toxicity : the case of aristolochic acids
    Abdullah, Rozaini - \ 2017
    Wageningen University. Promotor(en): Ivonne Rietjens, co-promotor(en): Ans Punt; Sebas Wesseling; Jochem Louisse. - Wageningen : Wageningen University - ISBN 9789463430807 - 207
    animal testing alternatives - in vitro - toxicity - models - risk assessment - toxins - carboxylic acids - alternatieven voor dierproeven - in vitro - toxiciteit - modellen - risicoschatting - toxinen - carbonzuren

    This PhD thesis aimed to provide additional evidence to demonstrate the potential of an integrated testing strategy using in vitro assays with physiologically based kinetic (PBK) modeling based-reverse dosimetry to predict in vivo toxicity without animal testing. Kidney toxicity was chosen as the toxicity endpoint and aristolochic acids (AAs) were selected as model chemicals. AAs are natural nephrotoxic, genotoxic and carcinogenic chemicals present in Aristolochia species. PBK models for rat, mouse and human were developed for aristolochic acid I (AAI) based on kinetic parameter values derived from in vitro incubations using relevant tissue fractions. Then, in vitro concentration-response curves for cytotoxicity of AAI were obtained in kidney cell lines and translated to in vivo dose-response curves for kidney toxicity using PBK modeling-based reverse dosimetry. The points of departure (PODs) obtained from these predicted in vivo dose-response curves generally fell within the range of PODs derived from in vivo literature data on kidney toxicity of AAI. The same PBK models were subsequently used to translate the in vitro concentration-response curves for AAI-DNA adduct formation to in vivo dose-response curves for kidney AAI-DNA adduct formation. The predicted in vivo AAI-DNA adduct formation in the rat, mouse and human kidney varied within an order of magnitude compared to the in vivo values reported in the literature. The PBK models were also used to predict the dose level that would be required in humans to obtain the level of DNA adducts in rats at the BMD10 (the benchmark dose causing a 10% extra risk above background level) value for AAI-induced tumor formation in the rat kidney. This analysis revealed that the dose level required to induce the level of DNA adduct formation that equals the DNA adduct level at the BMD10 were similar to AA doses estimated to be taken in Belgian patients that developed urinary tract cancer. Given that the exposure to AAI is often accompanied by the presence of AAII, in a next study the relative formation of DNA adducts by these two major AA congeners was investigated. The results revealed that the relative higher formation of AAI-DNA adducts as compared to AAII-DNA adducts observed in vitro was not reflected in vivo where the levels formed upon exposure to equal dose levels were relatively similar. PBK model based translation of the in vitro data to the in vivo situation revealed that PBK model based prediction of in vivo DNA adduct formation is feasible. However, predicted AAI-DNA adduct levels were higher than predicted AAII-DNA adduct levels, indicating that the difference between the in vitro and in vivo AAI-/AAII-DNA adduct ratios could only in part be explained by differences in in vivo kinetics of AAI compared to AAII. The discrepancy between the difference in DNA adduct formation of AAI and AAII in the in vitro and the in vivo situation is an issue that needs further investigation to also adequately predict the relative differences between the two AAs. In a final chapter this thesis aimed to investigate the possible risks associated with exposure to AAs based on AA levels measured in plant food supplements (PFS) and herbal products. This is of interest given the restrictions on the presence of AAs in food, installed in various countries including The Netherlands, after the incidences with induction of Aristolochic Acid Nephropathy upon use of herbal weight loss preparations that accidentally contained AAs. The risk assessment of PFS and herbal products containing AAs purchased via online markets revealed that consumers can still be exposed to AA-containing PFS and herbal products and that the corresponding levels of exposure raise concern especially for people who frequently use the products. Altogether, this thesis presented further support for the use of combined in vitro-PBK modeling based alternative tools for risk assessment and revealed the continued risks posed by AAs present in PFS and herbal products.

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