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Characterization and Management of Uncertainties in Toxicological Risk Assessment: Examples from the Opinions of the European Food Safety Authority

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Computational Toxicology

Part of the book series: Methods in Molecular Biology ((MIMB,volume 1800))

Abstract

Uncertainties can be defined as the gaps of knowledge and/or of data sets and/or of methodologies that can exert an unwanted influence on the outcome of a risk assessment. In principle, uncertainties are unavoidable, and thus, a transparent description and weighing of relevant uncertainties should be a necessary component of risk assessment. Examples are provided of uncertainty analysis in recent opinions of the European Food Safety Authority concerning additives, pesticides, and contaminants. Whereas it is difficult to quantify the impact of each specific uncertainty on the outcome, it should be possible to quantify the combined effect of identified uncertainties; also, a stepwise approach may be envisaged, focusing on those issues where a detailed appraisal of uncertainties is needed. On a more general ground, consideration of uncertainty and its sources meets the general requirement for transparency in scientific assessment.

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References

  1. FAO (Food and Agriculture Organization of the United Nations) and WHO (World Health Organization) (2009). Principles and methods for the risk assessment of chemicals in food. Environmental Health Criteria 240, http://www.who.int/foodsafety/publications/chemical-food/en/ (last visit September 2017)

  2. Dong Z, Liu Y, Duan L, Bekele D, Naidu R (2015) Uncertainties in human health risk assessment of environmental contaminants: a review and perspective. Environ Int 85:120–132

    Article  CAS  PubMed  Google Scholar 

  3. Aiassa E, Higgins JP, Frampton GK, Greiner M, Afonso A, Amzal B, Deeks J, Dorne JL, Glanville J, Lövei GL, Nienstedt K, O'connor AM, Pullin AS, Rajić A, Verloo D (2015) Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety. Crit Rev Food Sci Nutr 55:1026–1034

    Article  CAS  PubMed  Google Scholar 

  4. European Food Safety Authority (2017) Guidance on Uncertainty in EFSA Scientific Assessment. Revised Draft for Internal Testing. https://www.efsa.europa.eu/sites/default/files/160321DraftGDUncertaintyInScientificAssessment.pdf (last visit, January 2018)

  5. European Food Safety Authority (2014) Guidance on expert knowledge elicitation in food and feed safety risk assessment. EFSA J 12:3734. [278 pp]

    Article  Google Scholar 

  6. European Food Safety Authority, Scientific Committee (2009) Guidance of the scientific committee on a request from EFSA on the use of the benchmark dose approach in risk assessment. EFSA J 1150:1–72

    Google Scholar 

  7. European Food Safety Authority, Scientific Committee (2017) Update: guidance on the use of the benchmark dose approach in risk assessment. EFSA J 15:4658–5079

    Google Scholar 

  8. Frazzoli C, Robouch P, Caroli S (2010) Analytical accuracy for trace elements in food: a graphical approach to support uncertainty analysis in assessing dietary exposure. Toxicol Environ Chem 92:641–654

    Article  CAS  Google Scholar 

  9. European Food Safety Authority, Panel on Food Additives and Nutrient Sources added to Food (2017) Scientific opinion on the re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) as food additives. EFSA J 15:4786–4943

    Google Scholar 

  10. European Food Safety Authority, Pamel on Plant Protection Producys and their Residues (2017) Scientific opinion on the investigation into experimental toxicological properties of plant protection products having a potential link to Parkinson’s disease and childhood leukaemia. EFSA J 15:4691–5016

    Google Scholar 

  11. Mensinga TT, Speijers GJA, Meulenbelt J (2003) Health implications of exposure to environmental nitrogenous compounds. Toxicol Rev 22:41–51

    Article  CAS  PubMed  Google Scholar 

  12. European Food Safety Authority (2007) Scientific opinion of the scientific committee related to uncertainties in dietary exposure assessment. EFSA J 5:438–492

    Article  Google Scholar 

  13. IARC - International Agency for Research on Cancer (2010) Ingested nitrate and nitrite, and cyanobacterial peptide toxins. IARC Monogr Eval Carcinog Risks Hum 94:v–vii, 1–412

    Google Scholar 

  14. Organisation for Economic Co-operation and Development - OECD (2013) Guidance document on developing and assessing adverse outcome pathways. OECD, Paris. ENV/JM/MONO 6, p 45

    Google Scholar 

  15. Mantovani A (2017) Some considerations on adverse outcome pathways: how to use them in toxicological risk assessment. Adjacent Government August 2017, pp .130–131. http://edition.pagesuite-professional.co.uk/html5/reader/production/default.aspx? pubname=&edid=f8abf7ad-bc1b-4a51-b42b-d7b202a02971 (last visit, September 2017)

  16. Fujita KA, Ostaszewski M, Matsuoka Y, Ghosh S, Glaab E, Trefois C, Crespo I, Perumal TM, Jurkowski W, Antony PM, Diederich N, Buttini M, Kodama A, Satagopam VP, Eifes S, Del Sol A, Schneider R, Kitano H, Balling R (2014) Integrating pathways of Parkinson’s disease in a molecular interaction map. Mol Neurobiol 49:88–102

    Article  CAS  PubMed  Google Scholar 

  17. Pelkonen O, Terron A, Hernandez AF, Menendez P, Bennekou SH, EFSA WG EPI1 and its other members (Angeli K, Fritsche E, Leist M, Mantovani A, Price A, Viviani B) (2017) Chemical exposure and infant leukaemia: development of an adverse outcome pathway (AOP) for aetiology and risk assessment research. Arch Toxicol 91:2763–2780

    Article  CAS  PubMed  Google Scholar 

  18. Leist M, Ghallab A, Graepel R, Marchan R, Hassan R, Bennekou SH, Limonciel A, Vinken M, Schildknecht S, Waldmann T, Danen E, van Ravenzwaay B, Kamp H, Gardner I, Godoy P, Bois FY, Braeuning A, Reif R, Oesch F, Drasdo D, Höhme S, Schwarz M, Hartung T, Braunbeck T, Beltman J, Vrieling H, Sanz F, Forsby A, Gadaleta D, Fisher C, Kelm J, Fluri D, Ecker G, Zdrazil B, Terron A, Jennings P, van der Burg B, Dooley S, Meijer AH, Willighagen E, Martens M, Evelo C, Mombelli E, Taboureau O, Mantovani A, Hardy B, Koch B, Escher S, van Thriel C, Cadenas C, Kroese D, van de Water B, Hengstler JG (2017) Adverse outcome pathways: opportunities, limitations and open questions. Arch Toxicol 91:3477–3505

    Article  CAS  PubMed  Google Scholar 

  19. European Food Safety Authority, Panel on Additives and Products or Substances used in Animal Feed (2016) Scientific opinion on the safety of lancer (lanthanide citrate) as a zootechnical additive for weaned piglets. EFSA J 214(4477):10

    Google Scholar 

  20. European Food Safety Authority, Panel on Contaminants in the Food Chain (2017) Scientific opinion on the risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. EFSA J 14(4426):159

    Google Scholar 

  21. European Food Safety Authority, Panel on Contaminants in the Food Chain (2017) Scientific Opinion on the risks to human and animal health related to the presence of deoxynivalenol and its acetylated and modified forms in food and feed. EFSA J 15:4718. [345 pp]

    Google Scholar 

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Author information

Authors and Affiliations

  1. Department of Food Safety, Nutrition and Veterinary Public Health, Istituto Superiore di Sanità (ISS) viale Regina Elena, Rome, Italy

    Alberto Mantovani

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  1. Alberto Mantovani
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Correspondence to Alberto Mantovani .

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Editors and Affiliations

  1. Dipartimento di Farmacia-Scienze del Farmaco, Università degli Studi di Bari Aldo Moro, Bari, Italy

    Orazio Nicolotti

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Mantovani, A. (2018). Characterization and Management of Uncertainties in Toxicological Risk Assessment: Examples from the Opinions of the European Food Safety Authority. In: Nicolotti, O. (eds) Computational Toxicology. Methods in Molecular Biology, vol 1800. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-7899-1_10

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  • DOI: https://doi.org/10.1007/978-1-4939-7899-1_10

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-7898-4

  • Online ISBN: 978-1-4939-7899-1

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