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EFSA Scientific Report on the Establishment of Cags for Their Effects on the Nervous 52 System SCIENTIFIC REPORT ADOPTED: DD Month YYYY doi:10.2903/j.efsa.2019.NNNN 1 Cumulative dietary risk characterisation of pesticides that 2 have acute effects on the nervous system 3 European Food Safety Authority (EFSA) 4 Peter Craig, Bruno Dujardin, Andy Hart, Antonio F. Hernandez-Jerez, Susanne Hougaard 5 Bennekou, Carsten Kneuer, Bernadette Ossendorp, Ragnor Pedersen, Gerrit Wolterink, Luc 6 Mohimont 7 8 Abstract 9 A retrospective acute cumulative risk assessment of dietary exposure to pesticide residues, supported 10 by an uncertainty analysis by expert knowledge elicitation, was conducted for two effects on the nervous 11 system, brain and/or erythrocyte acetylcholinesterase inhibition and functional alterations of the motor 12 division. The pesticides considered in this assessment were identified and characterised in the scientific 13 report on the establishment of cumulative assessment groups of pesticides for their effects on the 14 nervous system. Cumulative exposure assessments were conducted through probabilistic modelling by 15 EFSA and the Dutch National Institute for Public Health and the Environment (RIVM) using two different 16 software tools. These exposure assessments used monitoring data collected by Member States under 17 their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual consumption data 18 from ten populations of consumers from different countries and different age groups. The exposure 19 assessments are reported in separate reports. Overall, taking account of the available data and the 20 uncertainties involved, it is concluded that cumulative exposure to pesticides that have acute effects on 21 the nervous system does not exceed the threshold for regulatory consideration established by risk 22 managers. 23 © European Food Safety Authority, 2019 24 25 Key words: pesticide residues, nervous system, cumulative risk assessment, probabilistic modelling, 26 expert knowledge elicitation 27 28 Requestor: EFSA 29 Question number: EFSA-Q-2018-00345 30 Correspondence: [email protected] 31 32 33 Acknowledgements: EFSA wishes to thank the following for the support provided to this scientific 34 output: Tamara Coja and Olavi Pelkonen, and the other members of the Panel on Plant Protection 35 Products and their Residues, for the scientific review and endorsement, respectively, of this scientific 36 output; EFSA staff members Daniela Brocca and Paula Medina for the support provided to this scientific 37 report. www.efsa.europa.eu/publications EFSA Journal 20YY;volume(issue):NNNN 38 Suggested citation: EFSA (European Food Safety Authority), Craig P, Dujardin B, Hart A, Hernandez- 39 Jerez AF, Hougaard Bennekou S, Kneuer C, Ossendorp B, Pedersen R, Wolterink G, Mohimont L, 2019. 40 Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system. 41 EFSA supporting publication 2019:EN-NNNN. 76 pp. doi:10.2903/sp.efsa.2019.EN-NNNN 42 ISSN: 2397-8325 43 © European Food Safety Authority, 2019 44 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/publications 2 EFSA Journal 20YY;volume(issue):NNNN Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system 45 Summary 46 A retrospective acute cumulative risk assessment (CRA) of dietary exposure to pesticide residues in 47 2014, 2015 and 2016 was conducted for two effects on the nervous system: brain and/or erythrocyte 48 acetylcholinesterase (AChE) inhibition, and functional alterations of the motor division. 49 The first step of the process was to establish cumulative assessment groups (CAG) of pesticides for 50 the effects of relevance so as to assess their combined toxicity on the nervous system. This step is 51 reported in the EFSA scientific report on the establishment of CAGs for their effects on the nervous 52 system. In that report, all effects of pesticides on the nervous system were reviewed and five were 53 found to meet the criteria established by the PPR Panel and to be specific for consideration in CRA. 54 Two CAGs (for brain and/or erythrocyte AChE inhibition and for functional alterations of the motor 55 division) were considered sufficient to cover the cumulative risks associated to all five specific effects. 56 In a second step, cumulative exposure assessments were conducted of pesticides included in the 57 CAGs for brain and/or erythrocyte AChE inhibition and for functional alterations of the motor division. 58 These were carried out by EFSA and the Dutch National Institute for Public Health and Environment 59 (RIVM) using probabilistic modelling and with different software tools. The results are reported in the 60 EFSA scientific report on cumulative dietary exposure assessment of pesticides that have acute effects 61 on the nervous system using SAS® software and in the external scientific report on cumulative dietary 62 exposure assessment of pesticides that have acute effects on the nervous system using MCRA software. 63 The two tools produced nearly identical results and any observed differences are mainly attributed to 64 the random effect of probabilistic modelling. These minor differences do not impact on the outcome of 65 the exposure assessment. 66 The exposure calculations used monitoring data collected by EU Member States (MSs) under their official 67 monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten 68 populations of consumers from different countries and from different age groups, including vulnerable 69 ones: four populations of adults, three populations of children (3 to 9 years) and three populations of 70 toddlers (1 to 3 years). 71 As agreed by risk managers in the Standing Committee on Plants, Animals, Food and Feed (SC PAFF), 72 the exposure estimates were conducted in a tiered approach. The first-tier calculations (tier I) use very 73 conservative assumptions for an efficient screening of the exposure with low risk for underestimation; 74 the second-tier assessment (tier II) includes assumptions that are more refined but still intended to be 75 conservative and therefore likely to overestimate the actual exposure. 76 For each scenario, exposure estimates relied on the principle of dose-addition. They were obtained for 77 different percentiles of the exposure distribution and the total margin of exposure (MOET) was 78 calculated at each percentile. In accordance with the threshold agreed at the SC PAFF, further regulatory 79 consideration would be required when the MOET calculated at the 99.9th percentile of the exposure 80 distribution is below 100. 81 The lowest MOET estimates were obtained with the CAG for brain and/or erythrocyte AChE inhibition. 82 According to the tier II scenario, estimates at the 50th, 95th and 99th percentile of the exposure 83 distribution were all well above 100. At the 99.9th percentile of the exposure distribution, estimates were 84 mostly below 100, ranging from 40 to 59 in toddlers and other children. For adults, the MOETs ranged 85 from 92 to 124. The exposure to this group of pesticides was predominantly driven by the occurrence 86 of chlorpyrifos, triazophos and omethoate. Other important contributors included dichlorvos, 87 formetanate and carbofuran. 88 For pesticides included in the CAG for functional alterations of the motor division, MOETs calculated at 89 the 99.9th percentile of the exposure distribution were higher, ranging from 63 to 89 in toddlers and 90 other children and from 141 to 176 in adults. In this case, the main drivers for the exposure were 91 identified as triazophos and deltamethrin. Other important contributions came from beta-cypermethrin, 92 omethoate, thiram, chlormequat and acrinathrin. 93 The last step of the exercise was a cumulative risk characterisation which was based on the 94 outcome of the first two steps and included an uncertainty analysis, performed following the guidance www.efsa.europa.eu/publications 3 EFSA Journal 20YY;volume(issue):NNNN Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system 95 of the EFSA Scientific Committee in order to take account of the limitations in the scientific knowledge 96 and data and of the assumptions used in all steps of the assessment. 97 Thirty-four sources of uncertainty affecting the input data, model assumptions and the assessment 98 methodology were identified. The impact of each source of uncertainty on the MOETs at the 99.9th 99 percentile of exposure was quantified. This showed that uncertainties had variable effects, with some 100 of them tending to overestimate the MOET (e.g. the metabolites were not considered in the assessment) 101 and others tending to underestimate it (e.g. limited availability of processing factors; when such data 102 are missing, it is assumed that all pesticide residues in the raw primary commodity will reach the end 103 consumer without any loss during household or industrial processing). The overall impact of the 104 uncertainties, and their dependencies, on the assessment was then quantified in a sequential approach 105 using expert knowledge elicitation (EKE) techniques and 1D Monte Carlo simulations. 106 As a result of this process, the MOETs at the 99.9th percentile and their confidence intervals were 107 adjusted to take account of the identified uncertainties. For both CAGs, the adjusted MOETs were around 108 4 to 5 times higher compared to
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