Use of food consumption data of food balance sheets and national food consumption surveys in deterministic long-term dietary exposure assessments of pesticides.

Deterministic long-term dietary exposure estimates of pesticide residues across different countries are called International Estimated Daily Intakes (IEDIs). Effect of using Food Balance Sheets (FBS) or National Food Consumption Surveys (NFCS) to calculate the IEDI was investigated. Presence of aggregated foods tended to increase the IEDI, and clustering of data from countries with comparable dietary patterns tended to decrease the IEDI. Furthermore, IEDIs for global use were not always at least as conservative as those for regional or national use. Risk assessors using these data should be aware of these limitations. As FBS data are only available for the general population and IEDIs are highest for children, a method was developed to convert FBS based IEDIs to indicative IEDIs for children. This may be appropriate if no NFCS data are available for this age group and the critical health-based guidance value is relevant for this age group.

Educational differences in healthy, environmentally sustainable and safe food consumption among adults in the Netherlands.

OBJECTIVE: To assess the differences in healthy, environmentally sustainable and safe food consumption by education levels among adults aged 19-69 in the Netherlands. DESIGN: This study used data from the Dutch National Food Consumption Survey 2007-10. Food consumption data were obtained via two 24-h recalls. Food consumption data were linked to data on food composition, greenhouse gas emissions (GHGe) and concentrations of contaminants. The Dutch dietary guidelines (2015), dietary GHGe and dietary exposure to contaminants were used as indicators for healthy, environmentally sustainable and safe food consumption, respectively. SETTING: The Netherlands. PARTICIPANTS: 2106 adults aged 19-69 years. RESULTS: High education groups consumed significantly more fruit (+28 g), vegetables (men +22 g; women +27 g) and fish (men +6 g; women +7 g), and significantly less meat (men -33 g; women -14 g) compared with low education groups. Overall, no educational differences were found in total GHGe, although its food sources differed. Exposure to contaminants showed some differences between education groups. CONCLUSIONS: The consumption patterns differed by education groups, resulting in a more healthy diet, but equally environmentally sustainable diet among high compared with low education groups. Exposure to food contaminants differed between education groups, but was not above safe levels, except for acrylamide and aflatoxin B1. For these substances, a health risk could not be excluded for all education groups. These insights may be used in policy measures focusing on the improvement of a healthy diet for all.

Probabilistic dietary risk assessment of triazole and dithiocarbamate fungicides for the Brazilian population.

Residue data for triazoles (TR) and dithiocarbamates (DT) in 30,786 samples of 30 foods were obtained from mainly two national monitoring programs, and consumption data from a national survey conducted among persons aged 10 years or older. About 16% of the samples contained TR, mainly grape (53.5%), and 16.2% contained DT, mainly apple (59.3%). Flusilazole was the index compound used for the acute effects of TR for women of child-bearing-age (cranium-facial malformation and skeletal variation), cyproconazole for the chronic effects of TR (hepatoxicity), and ethylene-bis-dithitiocarbamates (EBDC) for DT (thyroid toxicity). Exposures were estimated using the Monte Carlo Risk Assessment software. Different models were tested, and a Model-Then-Add approach was found to best estimate the chronic exposures to DT and TR. At the 99.9th percentile (P99.9), the cumulative acute TR intakes accounted for up to 0.5% of the flusilazole ARfD, mainly from beans and rice consumption. The chronic TR and DT intakes accounted for 1 and 6.7% of the respective index compound ADIs, with beans and rice accounting for most of the TR intake (∼70%), and apple for about 51-56% of the DT intake. The estimated risks from the exposure to TR and DT indicate no health concern for the Brazilian population.

Dietary cumulative acute risk assessment of organophosphorus, carbamates and pyrethroids insecticides for the Brazilian population.

Cumulative acute dietary risk assessments of organophosphorus (OPs), carbamates (CBs) and pyrethroids (PYs) were conducted for the Brazilian population. Residue data for 30786 samples of 30 foods were obtained from two national monitoring programs and one University laboratory, and consumption data from a national survey conducted among persons 10 years or older. Acephate and methamidophos were used as index compounds (IC) for OPs, oxamyl for CBs and deltamethrin for PYs. Exposures were estimated using the Monte Carlo Risk Assessment (MCRA 8.2) software. Orange and orange juice (mainly containing methidathion), pasta and salted bread (mainly pirimiphos-methyl) contributed most to the OPs intake. Rice accounted for 80% of the CBs intake (teenagers), mainly due to aldicarb. Pasta, salted bread and beans contributed most to the PYs intake (9-14%), mainly due to bifenthrin. The intake did not exceed the ARfD at the 99.9th percentile for OPs, CBs and PYs, and the risks from the exposure were not considered of health concern. When food consumption data become available for children under age 10, studies in the cumulative exposure should be conducted, as this age group is the most critical among the population, mainly due to their higher food consumption per kg body weight.

Cumulative dietary exposure to a selected group of pesticides of the triazole group in different European countries according to the EFSA guidance on probabilistic modelling.

The practicality was examined of performing a cumulative dietary exposure assessment according to the requirements of the EFSA guidance on probabilistic modelling. For this the acute and chronic cumulative exposure to triazole pesticides was estimated using national food consumption and monitoring data of eight European countries. Both the acute and chronic cumulative dietary exposures were calculated according to two model runs (optimistic and pessimistic) as recommended in the EFSA guidance. The exposures obtained with these model runs differed substantially for all countries, with the highest exposures obtained with the pessimistic model run. In this model run, animal commodities including cattle milk and different meat types, entered in the exposure calculations at the level of the maximum residue limit (MRL), contributed most to the exposure. We conclude that application of the optimistic model run on a routine basis for cumulative assessments is feasible. The pessimistic model run is laborious and the exposure results could be too far from reality. More experience with this approach is needed to stimulate the discussion of the feasibility of all the requirements, especially the inclusion of MRLs of animal commodities which seem to result in unrealistic conclusions regarding their contribution to the dietary exposure.

The MCRA model for probabilistic single-compound and cumulative risk assessment of pesticides.

Pesticide risk assessment is hampered by worst-case assumptions leading to overly pessimistic assessments. On the other hand, cumulative health effects of similar pesticides are often not taken into account. This paper describes models and a web-based software system developed in the European research project ACROPOLIS. The models are appropriate for both acute and chronic exposure assessments of single compounds and of multiple compounds in cumulative assessment groups. The software system MCRA (Monte Carlo Risk Assessment) is available for stakeholders in pesticide risk assessment at mcra.rivm.nl. We describe the MCRA implementation of the methods as advised in the 2012 EFSA Guidance on probabilistic modelling, as well as more refined methods developed in the ACROPOLIS project. The emphasis is on cumulative assessments. Two approaches, sample-based and compound-based, are contrasted. It is shown that additional data on agricultural use of pesticides may give more realistic risk assessments. Examples are given of model and software validation of acute and chronic assessments, using both simulated data and comparisons against the previous release of MCRA and against the standard software DEEM-FCID used by the Environmental Protection Agency in the USA. It is shown that the EFSA Guidance pessimistic model may not always give an appropriate modelling of exposure.

Computational tool for usual intake modelling workable at the European level.

In this paper two models present in the computational tool Monte Carlo Risk Assessment (MCRA) were compared for assessing the usual intake of lead in five countries. For this, we used national food consumption data organised according to the format of the European Food Safety Authority (EFSA) Comprehensive database and a single lead concentration database in which analysed commodities were organised according to EFSA's Standard Sampling Description (SSD) system. This meant that both input data were coded according to the hierarchical FoodEx1 classification system. We demonstrate that the naïve Observed Individual Means model resulted in more conservative estimates of the exposure in the right tail of the exposure distribution compared to a refined usual intake model, the LogisticNormal­Normal model. With MCRA, the usual intake could be estimated with both models using food consumption and concentration data that were coded according to the hierarchical FoodEx1 classification system demonstrating that this tool can be used in EFSA's data environment. Additionally, the computational tool has functionalities 1) to check the input data quality by presenting detailed information about these data around a specified percentile of exposure and 2) to decide whether the use of a more refined usual intake model is appropriate.

Phthalates dietary exposure and food sources for Belgian preschool children and adults.

Numerous studies have indicated that for phthalates, the intake of contaminated foods is the most important exposure pathway for the general population. Up to now, data on dietary phthalate intake are scarce and - to the authors' knowledge - not available for the Belgian population. Therefore, the purpose of this study was: (1) to assess the long-term intake of the Belgian population for eight phthalates considering different exposure scenarios (benzylbutyl phthalate (BBP); di-n-butyl phthalate (DnBP); dicyclohexyl phthalate (DCHP); di(2-ethylhexyl) phthalate (DEHP); diethyl phthalate (DEP); diisobutyl phthalate (DiBP); dimethyl phthalate (DMP), di-n-octyl phthalate (DnOP)); (2) to evaluate the intake of BBP, DnBP, DEP and DEHP against tolerable daily intake (TDI) values; and (3) to assess the contribution of the different food groups to the phthalate intake. The intake assessment was performed using two Belgian food consumption databases, one with consumption data of preschool children (2.5 to 6.5 years old) and another of adults (≥15 years old), combined with a database of phthalate concentrations measured in over 550 food products sold on the Belgian market. Phthalate intake was calculated using the 'Monte Carlo Risk Assessment' programme (MCRA 7.0). The intake of DEHP was the highest, followed by DiBP. The intake of BBP, DnBP and DEP was far below the TDI for both children and adults. However, for DEHP, the 99th percentile of the intake distribution of preschoolers in the worst case exposure scenario was equal to 80% of the TDI, respectively. This is not negligible, since other exposure routes of DEHP exist for children as well (e.g. mouthing of toys). Bread was the most important contributor to the DEHP intake and this may deserve further exploration, since the origin of this phthalate in bread remains unclear.

Comparison of different exposure assessment methods to estimate the long-term dietary exposure to dioxins and ochratoxin A.

Long-term exposures to dioxins (PCCD/F and dioxin-like PCBs) and ochratoxin A were calculated using food consumption data of the European concise database combined with concentration data of the Netherlands (NL) using a deterministic approach. To refine these assessments, exposures were also calculated using three long-term exposure models, observed individual means (OIM), Iowa State University Foods (ISUF), and betabinomial-normal (BBN) models, combined with individual food consumption data of NL. BBN and ISUF correct the variation in long-term exposure for the within-person variation, whereas OIM calculates the mean exposure over the days in the food consumption survey. Exposures obtained with the concise database were highest, and those obtained with OIM higher than with BBN and ISUF. Contribution of the major sources of exposure differed between the concise database and the three models. Given the constraints of the concise database, exposures obtained with this database should be interpreted as a first tier assessment. Preferably, refined assessments using models that correct the variation in long-term exposure for the within-person variation combined with individual food consumption data and national concentration data should be used to assess the long-term exposure. We recommend the use of BBN since it can model exposure distributions that depend on covariates.

Dietary exposure assessments for children in europe (the EXPOCHI project): rationale, methods and design.

BACKGROUND/PURPOSE: The number of dietary exposure assessment studies focussing on children is very limited. Children are however a vulnerable group due to their higher food consumption level per kg body weight. Therefore, the EXPOCHI project aims 1 to create a relational network of individual food consumption databases in children, covering different geographical areas within Europe, and 2 to use these data to assess the usual intake of lead, chromium, selenium and food colours. METHODS: EXPOCHI includes 14 food consumption databases focussed on children (1-14 y old). The data are considered representative at national/regional level: 14 regions covering 13 countries. Since the aim of the study is to perform long-term exposure assessments, only data derived from 24 hr dietary recalls and dietary records recorded on at least two non-consecutive days per individual were included in the dietary exposure assessments. To link consumption data and concentration data of lead, chromium and selenium in a standardised way, categorisation of the food consumption data was based on the food categorisation system described within the SCOOP Task report 3.2.11. For food colours, the food categorisation system specified in the Council Directive 94/36/EC was used. CONCLUSION: The EXPOCHI project includes a pan-European long-term exposure assessment of lead, chromium, selenium and food colours among children living in 13 different EU countries. However, the different study methods and designs used to collect the data in the different countries necessitate an in-depth description of these different methods and a discussion about the resulting limitations.

Probabilistic risk assessment of dietary exposure to single and multiple pesticide residues or contaminants: summary of the work performed within the SAFE FOODS project.

This introduction to the journal's supplement on probabilistic risk assessment of single and multiple exposure to pesticide residues or contaminants summarizes the objectives and results of the work performed in work package 3 of the EU-funded project SAFE FOODS. Within this work package, we developed an electronic platform of food consumption and chemical concentration databases harmonised at raw agricultural commodity level. In this platform the databases are connected to probabilistic software to allow probabilistic modelling of dietary exposure in a standardised way. The usefulness of this platform is demonstrated in two papers, which describe the exposure to pesticides and glycoalkaloids in several European countries. Furthermore, an integrated probabilistic risk assessment (IPRA) model was developed: a new tool to integrate exposure and effect modelling, including uncertainty analyses. The use of this model was shown in a paper on the cumulative exposure to anti-androgen pesticides. Combined with a health impact prioritization system, developed within this work package to compare heath risks between chemicals, the IPRA tool can also be used to compare health risks between multiple chemicals in complex risk assessment situation such as risk-benefit and risk trade-off analyses. Both the electronic platform of databases as the IPRA model may proof to be powerful tools to tackle the challenges risk managers are or will be faced with in the future.

Probabilistic cumulative risk assessment of anti-androgenic pesticides in food.

In this paper, we present a cumulative risk assessment of three anti-androgenic pesticides (vinclozolin, procymidone and prochloraz) using the relative potency factor (RPF) approach and an integrated probabilistic risk assessment (IPRA) model. RPFs for each substance were estimated for three reproductive endpoints (ano-genital distance, and weights of the seminal vesicles and the musculus levator ani/bulbocavernosus) in male rat foetuses exposed in utero. The cumulative dietary intake was estimated based on consumption data and residue data from the Netherlands. The IPRA model combines variability in both exposure and sensitivity between individuals into a distribution of individual margins of exposures (IMoEs) and IMoEs of 1 or less indicate a possible concern. The assessment did not result in IMoEs < or = 1. The endpoint 'weight of seminal vesicles' resulted in the lowest IMoEs (0.1th percentile: 198) and the fraction of individuals with IMoEs<1000 was 1.43%. For the two other endpoints, the fractions were slightly lower. Thus, cumulative dietary exposure of Dutch women to vinclozolin, procymidone and prochloraz is not likely to be of concern for the reproductive development of their male foetuses. However, other anti-androgenic substances and exposure routes should also be included in the cumulative assessment to make it more comprehensive.

Harmonisation of food consumption data format for dietary exposure assessments of chemicals analysed in raw agricultural commodities.

In this paper, we present an approach to format national food consumption data at raw agricultural commodity (RAC) level. In this way, the data is both formatted in a harmonised way given the comparability of RACs between countries, and suitable to assess the dietary exposure to chemicals analysed in RACs at a European level. In this approach, consumption data needs to be converted to edible part of RAC (e-RAC) level using a RAC conversion database. To subsequently use this data in exposure assessments, both e-RACs and RACs analysed in chemical control programmes should be classified via a uniform system. Furthermore, chemical concentrations in RACs may need to be converted to e-RAC level using processing factors. To illustrate the use of this approach, we describe how the Dutch RAC conversion database was used to convert consumption data of four national consumption surveys to e-RAC level, and the use of the FAO/WHO Codex Classification system of Foods and Animal Feeds to harmonise the classification. We demonstrate that this approach works well for pesticides and glycoalkaloids, and is an essential step forward in the harmonisation of risk assessment procedures within Europe when addressing chemicals analysed in RACs by all national food control systems.

Probabilistic acute dietary exposure assessments to captan and tolylfluanid using several European food consumption and pesticide concentration databases.

Probabilistic dietary acute exposure assessments of captan and tolylfluanid were performed for the populations of the Czech Republic, Denmark, Italy, the Netherlands and Sweden. The basis for these assessments was national databases for food consumption and pesticide concentration data harmonised at the level of raw agricultural commodity. Data were obtained from national food consumption surveys and national monitoring programmes and organised in an electronic platform of databases connected to probabilistic software. The exposure assessments were conducted by linking national food consumption data either (1) to national pesticide concentration data or (2) to a pooled database containing all national pesticide concentration data. We show that with this tool national exposure assessments can be performed in a harmonised way and that pesticide concentrations of other countries can be linked to national food consumption surveys. In this way it is possible to exchange or merge concentration data between countries in situations of data scarcity. This electronic platform in connection with probabilistic software can be seen as a prototype of a data warehouse, including a harmonised approach for dietary exposure modelling.

Comparison of two models for the estimation of usual intake addressing zero consumption and non-normality.

Various models exist for estimating the usual intake distribution from dietary intake data. In this paper, we compare two of these models, the Iowa State University Foods (ISUF) model and the betabinomial-normal (BBN) model and apply them to three different datasets. Intake data are obtained by aggregating over multiple food products and are often non-normal. The ISUF and BBN model both address non-normality. While the two models have similar structures, they show some differences. The ISUF model includes an additional spline transformation for improving the normality of the intake amount distribution, while the BBN model includes the possibility of addressing covariates, such as age or sex. Our analyses showed that for two of the example datasets both models produced similar estimates of the higher percentiles of the usual intake distribution. However, for the third dataset, where the intake amount distribution appear to be multimodal, both models produced different percentile estimates.

Comparison of human health risks resulting from exposure to fungicides and mycotoxins via food.

The interest in holistic considerations in the area of food safety is increasing. Risk managers may face the problem that reducing the risk of one compound may increase the risk of another compound. An example is the potential increase in mycotoxin levels due to a reduced use of fungicides in crop production. The Integrated Probabilistic Risk Assessment (IPRA) model was used to compare the estimated health impacts on humans caused by crops contaminated with the fungicides spiroxamine (SPI) and tebuconazole (TEB) or with the mycotoxins deoxynivalenol (DON) and zearalenone (ZEA). The IPRA model integrates a distribution characterising the exposure of individuals with a distribution characterising the susceptibility of individuals towards toxic effects. Its outcome, a distribution of Individual Margins of Exposure (IMoE), served as basis to perform comparisons of compounds, effects, countries, and population groups. Based on the available data and the assumptions made, none of the four compounds was found to have impact on human health in the addressed scenarios. The IMoE distributions were located as follows: DON

An integrated probabilistic framework for cumulative risk assessment of common mechanism chemicals in food: an example with organophosphorus pesticides.

This paper presents a framework for integrated probabilistic risk assessment of chemicals in the diet which accounts for the possibility of cumulative exposure to chemicals with a common mechanism of action. Variability between individuals in the population with respect to food consumption, concentrations of chemicals in the consumed foods, food processing habits and sensitivity towards the chemicals is addressed by Monte Carlo simulations. A large number of individuals are simulated, for which the individual exposure (iEXP), the individual critical effect dose (iCED) and the ratio between these values (the individual margin of exposure, iMoE) are calculated by drawing random values for all variable parameters from databases or specified distributions. This results in a population distribution of the iMoE, and the fraction of this distribution below 1 indicates the fraction of the population that may be at risk. Uncertainty in the assessment is treated as a separate dimension by repeating the Monte Carlo simulations many times, each time drawing random values for all uncertain parameters. In this framework, the cumulative exposure to common mechanism chemicals is addressed by incorporation of the relative potency factor (RPF) approach. The framework is demonstrated by the cumulative risk assessment of organophosphorus pesticides (OPs). By going through this example, the various choices and assumptions underlying the cumulative risk assessment are made explicit. The problems faced and the solutions chosen may be more generic than the present example with OPs. This demonstration may help to familiarize risk assessors and risk managers with the somewhat more complex output of probabilistic risk assessment.

A semi-quantitative model for risk appreciation and risk weighing.

Risk managers need detailed information on (1) the type of effect, (2) the size (severity) of the expected effect(s) and (3) the fraction of the population at risk to decide on well-balanced risk reduction measures. A previously developed integrated probabilistic risk assessment (IPRA) model provides quantitative information on these three parameters. A semi-quantitative tool is presented that combines information on these parameters into easy-readable charts that will facilitate risk evaluations of exposure situations and decisions on risk reduction measures. This tool is based on a concept of health impact categorization that has been successfully in force for several years within several emergency planning programs. Four health impact categories are distinguished: No-Health Impact, Low-Health Impact, Moderate-Health Impact and Severe-Health Impact. Two different charts are presented to graphically present the information on the three parameters of interest. A bar plot provides an overview of all health effects involved, including information on the fraction of the exposed population in each of the four health impact categories. Secondly, a Health Impact Chart is presented to provide more detailed information on the estimated health impact in a given exposure situation. These graphs will facilitate the discussions on appropriate risk reduction measures to be taken.