Scientific Opinion on Risk Assessment for a Selected Group of Pesticides from the Triazole Group to Test Possible Methodologies to Assess Cumulative Effects from Exposure through Food from these Pesticides on Human Health

EFSA Journal

Volumn 7, Issue 9, 2009, Pages

[No Author Info available]

Author keywords

acute exposures; cumulative assessment group; Cumulative risk assessment; dietary exposure; MRL; residue monitoring; tiered approach; triazole chronic exposures

Indexed keywords

EID: 84938688212     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2009.1167     Document Type: Article

References (62)

1. Anonymous, 1998. Zo eet Nederland 1998. Resultaten van de voedselconsumptiepeiling 1997–1998 (Results of the Dutch National Food Consumption Survey 1997–1998). Den Haag, Voedingscentrum.
2. Becker, W., 1999. “Riksmaten 1997 – 1998. Svenskarna äter nyttigare - allt fler väljer grönt (Riksmaten 1997- 998. The Swedes eat more healthy).” Voar Föda 51, 24–27.
3. Becker, W. and Pearson, M., 2002. Riksmaten 1997-98. Dietary habits and nutrient intake in Sweden 1997–98. The second national food consumption survey. Uppsala, National Food Administration.
4. Boggio, V., Grossirod, A., Guyon, S., Fuchs F. and Fantino, F., 1999. Consommation alimentaire des nourrissons et des enfants en bas ages en France en 1997. Archives Pediatriques 6, 740–747.
5. Boon, P.E., van der Voet, H. and van Klaveren, J.D., 2003. Validation of a probabilistic model of dietary exposure to selected pesticides in Dutch infants. Food additive and Contaminants 20, Suppl. 1, 36–49.
6. Boon, P.E., Tjoe Nij, E.I.M., Koopman, N. and van Klaveren, J.D., 2004. Dietary habits and exposure to pesticides in Dutch infants (2004.017). RIKILT - Institute of Food Safety, Wageningen UR.
7. Boon, P.E., Ruprich, J., Petersen A., Moussavian, S., Debegnach, F, van Klaveren, J.D., (submitted). Harmonisation of food consumption data format for dietary exposure assessments of chemicals analysed in raw agricultural commodities.
8. Boon, P.E., Svensson, K., Moussavian, S., van der Voet, H., Petersen, A., Ruprich, J., Debegnach, F., de Boer, W.J., van Donkersgoed, G., Brera, C., van Klaveren, J.D. and Busk, L., 2009. Probabilistic acute dietary exposure assessments to captan and tolylfluanid using several European food consumption and pesticide concentration databases. Food and Chemical Toxicology, doi:10.1016/j.fct.2009.01.040
9. Chen, P.-J., Padgett, W.T., Moore, T., Winnik, W., Lambert, G.R., Thai, S.-F., Hester, S.D. and Nesnow, S., 2009. Three conazoles increase hepatic microsomal retinoic acid metabolism and decrease mouse hepatic retinoic acid levels in vivo. Toxicology and Applied Pharmacology, 234 (2), 143–155.
10. Codex (Codex Alimentarius Commission), 2007. Procedural Manual 17th Edition.
11. de Boer, W.J. and van der Voet, H., 2007. MCRA, Release 6. A web-based programme for Monte Carlo Risk Assessment, Biometris and RIKILT-Institute of Food Safety, Wageningen UR, Wageningen and National Institute for Public Health and the Environment (RIVM), Bilthoven.
12. de Boer, W.J., van der Voet, H., Bokkers, B.G.H., Bakker, M.I. and Boon, P.E., (submitted). A comparison of two models for estimating usual intake when consumption data include many zeros.
13. Dodd, K.W., 1996. A technical guide to C-SIDE (96-TR 32). Ames, Iowa: Department of Statistics and Center for Agricultural and Rural Development, Iowa State University. Available at:www.card.iastate.edu/publications/DBS/PDFFiles/96tr32.pdf
14. EC (European Commission), 2008. Guidelines on comparability, extrapolation, group tolerance and data requirements for setting MRLs. Health & Consumer Protection Directorate (SANCO). Doc. 7525/VI/95-rev.8 (01/02/2008).
15. EFSA (European Food Safety Authority), 2005. Opinion of the Scientific Panel on Plant health, Plant protection products and their Residues on a request from Commission related to the appropriate variability factor(s) to be used for acute dietary exposure assessment of pesticide residues in fruit and vegetables. 16 February 2005. The EFSA Journal (2005) 177, 1–61
16. EFSA (European Food Safety Authority), 2006a. Guidance of the Scientific Committee on a request from EFSA related to Uncertainties in Dietary Exposure Assessment. 14 December 2006. The EFSA Journal (2006) 438, 1–54.
17. EFSA (European Food Safety Authority), 2007a. Reasoned opinion on the potential chronic and acute risks to consumers' health arising from proposed temporary EU MRLs according to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in food and feed of plant and animal origin. 15 March 2007. The EFSA Journal (2007) 115, 1–161.
18. EFSA (European Food Safety Authority), 2007b. Opinion of the Scientific Panel on Plant protection products and their Residues on a request from the Commission on acute dietary intake assessment of pesticide residues in fruit and vegetables. 19 April 2007. The EFSA Journal (2007) 538, 1–88.
19. EFSA (European Food Safety Authority), 2008a. Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR Panel) on a request from the EFSA evaluate the suitability of existing methodologies and, if appropriate, the identification of new approaches to assess cumulative and synergistic risks from pesticides to human health with a view to set MRLs for those pesticides in the frame of Regulation (EC) 396/2005. The EFSA Journal (2008) 704, 1–88.
20. EFSA (European Food Safety Authority), 2008b. EFSA Scientific Report,. Addendum to the reasoned opinion on the potential chronic and acute risks to consumers' health arising from proposed temporary EU MRLs according to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in food and feed of plant and animal origin. 15 February 2008. The EFSA Journal 132, 1–317.
21. EFSA (European Food Safety Authority), 2008c. PRIMo: Pesticide Residue Intake Model.
22. EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on the use of the benchmark dose approach in risk assessment. 26 May 2009. The EFSA Journal (2009) 1150, 1–72.
23. Elia, M., Moretto, A. and Visentin, S., 2006. SAFEFOODNET: An ongoing project on chemical food safety: Network for enlarging Europe. In: Chemicals as intentional and accidental global environmental threats. Simeonov L, Chirila E (eds.), Springer, pp. 237–246.
24. EPA (U.S. Environmental Protection Agency), 2000. Assigning values to non- detected/non-quantified pesticide residues in human-health food exposure assessments. March 23, 2000
25. EPA (U.S. Environmental Protection Agency), 2006. 1,2,4-Triazole, triazole Alanine, Triazole Acetic Acid: Human Health Aggregate Risk Assessment in Support of Reregistration and Registration Actions for Triazole-derivative Fungicide Compounds. Washington, DC. www.epa.gov/opprd001/factsheets/tetraHHRA.pdf
26. FAO/WHO (Food and Agriculture Organization/World Health Organization), 1990. Pesticide Residues in Food – 1990 evaluations. Toxicology. World Health Organisation. WHO/PCS91.47,1991, nos 802–816 on INCHEM.
27. FAO/WHO, (Food and Agriculture Organization/World Health Organization), 1995. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and WHO Toxicological and Environmental Core Assessment Groups. FAO Plant Production and Protection Paper, 133, 1996.
28. FAO/WHO, (Food and Agriculture Organization/World Health Organization), 1997. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group. FAO Plant Production and Protection Paper, 145, 1998.
29. FAO/WHO (Food and Agriculture Organization/World Health Organization), 1998. Pesticide Residues in Food – 1998: part II Toxicological/ Joint Meeting of the FAO Panel of Experts on Pesticides Residues in Food and the Environment and the WHO Core Assessment Group, WHO/PC/S99.18.
30. FAO/WHO (Food and Agriculture Organization/World Health Organization), 1999. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group. FAO Plant Production and Protection Paper, 148, 1999.
31. FAO/WHO (Food and Agriculture Organization/World Health Organization), 2002. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group. FAO Plant Production and Protection Paper, 172, 2002.
32. FAO/WHO, (Food and Agriculture Organization/World Health Organization), 2004. Pesticide residues in food – 2004: Toxicological evaluations: part II / Joint Meeting of the FAO Panel of Experts on Pesticides Residues in Food and the Environment and the WHO Core Assessment Group, Rome, Italy 20–29 September 2004, WHO/PCS/06.1.
33. FAO/WHO, (Food and Agriculture Organization/World Health Organisation), 2007. Pesticide Residues in Food – 2007. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residue in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues. Plant Production and Protection Paper 191 (Rome: WHO, FAO).
34. FAO/WHO, (Food and Agriculture Organization/World Health Organization), 2008. Pesticide residues in food – 2008: Report of the Joint Meeting of the FAO Panel of Experts on Pesticides Residues in Food and the Environment and the WHO Core Assessment Group, Plant Production and Protection Paper 193 (Rome, 2009).
35. Goetz, A.K., Ren, H., Schmid, J.E., Blystone, C.R., Thillainadarajah, I., Best, D.S., Nichols, H.P., Strader, L.F., Wolf, D.C., Narotsky, M.G., Rockett, J.C. and Dix, D.J., 2007. Disruption of testosterone homeostasis as a mode of Action for the reproductive toxicity of triazole fungicides in the male rat. Toxicological sciences 95 (1), 227–239.
36. Lopez, A., Rueda, C., Armentia, A., Rodriguez, M., Cuervo and Ociuo, L.A., 2003. Validation and sensitivity analysis of a probabilistic model for dietary intake assessment to pesticide residues with a Basque Country duplicate diet study. Food additive and Contaminants 20 (Suppl. 1), 87–101
37. Madelin, R., 2004. The importance of scientific advice in the Community decision makingprocess. Opening address to the Inaugural Joint Meeting of the members of the Non-Food Scientific Committees. Directorate General for Health and Consumer Protection, European Commission, Brussels.
38. Menegola, E., Broccia, M.L., Di Renzo, F., Massa, V. and Giavini, E., 2005. Study on the common teratogenic pathway elicited by the fungicides triazole-derivatives. Toxicology in Vitro 19, 737–748.
39. Menegola, E., Broccia, M.L., Di Renzo, F., Massa, V. and Giavini, E., 2006. Postulated pathogenic pathway in triazole fungicide induced dysmorphogenic effects. Reproductive Toxicology 22, 186–195.
40. Nichele, V., Andrieu, E., Boizot, C., Caillavet F. and Darmon, N., 2005. La consommation d'aliments et de nutriments en France – Evolution 1969–2001. Institut National de la Recherche Argonomique – CORELA, Doc 05-07. Yvry-Sur-Seine, France.
41. Nusser, S.M., Carriquiry, A.L., Dodd, K.W. and Fuller, W.A., 1996. A semiparametric transformation approach to estimating usual daily intake distributions. Journal of the American Statistical Association 91, 1440–1449.
42. Nusser S.M., Fuller, W.A. and Guenther, P.M., 1997. Estimating usual dietary intake distributions: adjusting for measurement error and nonnormality in 24-hour food intake data. In: Survey Measurement and Process Quality. Lyberg, L., Biemer P., Collins, M., DeLeeuw, E., Dippo, C., Schwartz, N. and Trewin, D. (eds.). New York, Wiley. pp. 689–709.
43. OECD (Organization for Economic Cooperation and Development), 2001. OECD guideline for testing of chemicals. Guideline 414: Prenatal development toxicity study.
44. Ruprich, J., Dofkova, M., Rehurkova, I., Slamenikova, E. and Resova, D., 2006. Individual food consumption - the national study SISP04. Prague, CHFCH NIPH.
45. Rockett, J.C., Narotsky, M.G., Thompson, K.E., Thillainadarajah, I., Blystone, C.R., Goetz, A.K., Ren, H., Best, D.S., Murrell, R.N., Nichols, H.P., Schmid, J.E., Wolf, D.C. and Dix, D.J., 2006. Effect of conazole fungicides on reproductive development in the female rat. Reproductive Toxicology 22, 647–658.
46. Ross, A.J., Moore, T. and Leavitt, S.A. 2009. In vivo mutagenicity of conazole fungicides correlates with tumorigenicity. Mutagenesis, 24 (2), 149–152.
47. Slob, W. 2006. Probabilistic dietary exposure assessment taking into account variability in both amount and frequency of consumption. Food and Chemical Toxicology 44, 933–951.
48. Taxvig, C., Haas, U., Axelstad, M., Dalgaard, M., Boberg, J., Andersen, H.R. and Vingaard, A.M., 2007. Endocrine-disrupting activities in vivo of the fungicides tebuconazole and epoxiconazole. Toxicological sciences 100 (20), 464–473.
49. Tully, D.B., Bao, W., Goetz, A.K., Blystone, C.R., Ren, H., Schmid, J.E., Strader, L.F., Wood, C.R., Best, D.S., Narotsky, M.G., Wolf, D.C., Rockett, J.C. and Dix, D.J. 2006. Gene expression profiling in liver and testis of rats to characterize the toxicity of triazole fungicides. Toxicology and Applied Pharmacology 215, 260–273.
50. Turrini, A., Saba, A., Perrone, D., Cialfa, E. and D'Amicis, A., 2001. Food consumption patterns in Italy: the INN-CA Study 1994–1996. European Journal of Clinical Nutrition 55, 571–588.
51. van Dooren, M.M.H., Boeijen, I., van Klaveren, J.D. and van Donkersgoed, G., 1995. Conversie van consumeerbare voedingsmiddelen naar primaire agrarische produkten (Conversion of consumed foods into raw agricultural commodities). Wageningen, RIKILT-DLO: 22.
52. van Klaveren, J.D., van Donkersgoed, G., van der Voet, H., Stephenson, C. and Boon, P.E., 2009. Cumulative exposure assessment of triazole pesticides. RIKILT Report 2009.008.
53. Volatier, J.-L., 2000. Enquête INCA individuelle et nationale sur les consommations alimentaires. Tech & Doc, Paris, Agence Française de Sécurité Sanitaire des Aliments (AFSSA).
54. Ward, W.O., Delker, D.A., Hester, S.D., Thai, S.-F., Wolf, D.C., Allen, J.W. and Nesnow, S., 2006. Transcriptional profiles in liver from mice treated with hepatotumorigenic and non-hepatotumorigenic triazole conazole fungicides: propiconazole, triadimefon, and myclobutanil. Toxicologic Pathology, 34:7, 863–878
55. Wolf, D.C., Allen, J. W., George, M.H., Hester, S.D., Guobin Sun, Moore, T., Thai, S.-F., Delker, D.A., Winkfield, E., Leavitt, S., Nelson, G., Roop, B.C., Jones, C., Thibodeaux, J., Nesnow, S. 2006. Toxicity Profiles in Rats Treated with Tumorigenic and Nontumorigenic Triazole Conazole Fungicides: Propiconazole, Triadimefon, and Myclobutanil. Toxicologic Pathology, 34: 895–902.
56. WHO (World Health Organization), 1997a. Guidelines for predicting dietary intake of pesticide residues (WHO/FSF/FOS/97.7). Geneva: World Health Organization.
57. WHO (World Health Organization), 1997b. Food consumption and exposure assessment of chemicals. Report of a FAO/WHO consultation. Geneva. Switzerland Guidelines for pr
58. WHO (World Health Organization), 2003. GEMS/Food Regional Diets, Global Environment Monitoring System/Food Contamination Monitoring and Assessment Programme, Food Safety Department, World Health Organisation (WHO), Geneva, Switzerland.
59. WHO (World Health Organization), 2006. GEMS/Food Consumption Cluster Diets, Global Environmental Monitoring System – Food Contamination Monitoring and Assessment Programme, Food Safety Department, World Health Organisation (WHO), Geneva, Switzerland.
60. WHO (World Health Organization), 2008a. DIETARY EXPOSURE ASSESSMENT OF CHEMICALS IN FOOD Report of a Joint FAO/WHO Consultation Annapolis, Maryland, USA 2–6 May 2005,
61. WHO (World Health Organization), 2008b. International Programme on Chemical Safety (IPCS) Draft IPCS Framework and Sample Case Study. Combined exposure to Multiple Chemicals. February 25th/08.
62. Zarn, J.A., Brüschweiler, B.J. and Schlatter, J.R., 2003. Azole fungicides affect mammalian steroidogenesis by inhibiting sterol 14α-demethylase and aromatase. Environmental Health Perspectives, 111, 255–261.