Regulation of non-relevant metabolites of plant protection products in drinking and groundwater in the EU: Current status and way forward

Regulatory Toxicology and Pharmacology

Volumn 73, Issue 1, 2015, Pages 276-286

  Laabs, V ^a   Leake, C ^b   Botham, P ^c   Melching Kollmuss S ^a  

^a BASF SE   (Germany)

^b BAYER CROPSCIENCE AG   (Germany)

^c JEALOTT S HILL INTERNATIONAL RESEARCH CENTRE   (United Kingdom)

Author keywords

Drinking water; Groundwater; Non relevant metabolite; Pesticide; Regulation; Threshold of toxicological concern; TTC

Indexed keywords

DRINKING WATER; GROUND WATER; PESTICIDE; PLANT PROTECTION PRODUCT; UNCLASSIFIED DRUG; WATER POLLUTANT;

ARTICLE; AUSTRIA; DENMARK; ENVIRONMENTAL MONITORING; EUROPEAN UNION; FRANCE; GERMANY; GOVERNMENT REGULATION; HUMAN; LAW; LEGAL ASPECT; METABOLITE; NETHERLANDS; NON RELEVANT METABOLITE; PRIORITY JOURNAL; PUBLIC HEALTH; THRESHOLD OF TOXICOLOGICAL CONCERN; TOXICOLOGY; UNITED KINGDOM; WATER TREATMENT; CHEMISTRY; EUROPE; PROCEDURES; RISK ASSESSMENT; WATER MANAGEMENT; WATER POLLUTANT; WATER SUPPLY;

ENVIRONMENTAL MONITORING; EUROPE; GROUNDWATER; PESTICIDES; RISK ASSESSMENT; WATER POLLUTANTS, CHEMICAL; WATER PURIFICATION; WATER SUPPLY;

EID: 84938405048     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2015.06.023     Document Type: Article

References (59)

1. BMG Aktionswerte bezüglich nicht relevanter Metaboliten von Pflanzenschutzmittel-Wirkstoffen in Wasser für den menschlichen Gebrauch 2014, Bundesministerium für Gesundheit, Österreich, Erlass BMG-75210/0030-II/B/14/2014 vom 28.10.2014.
2. BMG Aktionswerte bezüglich nicht relevanter Metaboliten von Pflanzenschutzmittel-Wirkstoffen in Wasser für den menschlichen Gebrauch 2010, Bundesministerium für Gesundheit, Österreich, Erlass BMG-75210/0010-II/B/13/2010 vom 26.11.2010.
3. Boobis A., Budinsky R., Collie S., Crofton K., Embry M., Felter S., Hertzberg R., Kopp D., Mihlan G., Mumtaz M., Price P., Solomon K., Teuschler L., Yang R., Zaleski R. Critical analysis of literature on low-dose synergy for use in screening chemical mixtures for risk assessment. Crit. Rev. Toxicol. 2011, 41:369-383.
4. Cramer G.M., Ford R.A., Hall R.L. Estimation of toxic hazard - a decision tree approach. Food Cosmet. Toxicol. 1978, 16:255-276.
5. Defra River Basin Districts Typology, Standards and Groundwater Threshold Values (Water Framework Directive) (England and Wales) Direction 2009 2009, Web only publication:. http://archive.defra.gov.uk/environment/quality/water/wfd/documents/2010directions.pdf.
6. Dekant W., Melching-Kollmuß S., Kalberlah F. Toxicity assessment strategies, data requirements, and risk assessment approaches to derive health based guidance values for non-relevant metabolites of plant protection products. Regul. Toxicol. Pharmacol. 2010, 56:135-142.
7. Dolan T., Howsam P., Parsons D.J., Whelen M.J. Is the EU drinking water directive standard for pesticides in drinking water consistent with the precautionary principle?. Environ. Sci. Technol. 2013, 47:4999-5006.
8. DWI Guidance on the Implementation of the Water Supply (Water Quality) Regulations 2000 (as Amended) in England 2010, Drinking Water Inspectorate, September 2010.
9. EC Commission communication in the framework of the implementation of commission regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with regulation (EC) No 1107/2009 of the European parliament and of the council concerning the placing of plant protection products on the market, 2013/C 95/01. Off. J. Eur. Union 2013, 56:1-20.
10. EC Commission regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with regulation (EC) No 1107/2009 of the European parliament and of the council concerning the placing of plant protection products on the market. Off. J. Eur. Union L 2013, 93:1-84.
11. EC Regulation (EC) No 1107/2009 of the European parliament and of the council of 21 October 2009 concerning the placing of plant protection products on the market and repealing council directives 79/117/EEC and 91/414/EEC. Off. J. Eur. Union L 2009, 309:1-50.
12. EC Directive 2008/105/EC of the European parliament and of the council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing council directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending directive 2000/60/EC of the European parliament and of the council. Off. J. Eur. Union L 2008, 348:84-97.
13. EC Ihr Brief vom 9. Januar 2007 über Pestizidmetaboliten im Zusammenhang mit der Richtlinie 98/83/EG 2007, Letter from DG Environment ENV.D2 to Ministerium für Ernährung und Ländlichen Raum Baden-Württemberg, Germany. ENV.D.2/JC/bf D(2007) 4130, dated 23.03.2007.
14. EC Directive 2006/118/EC of the European parliament and of the council of 12 December 2006 on the protection of groundwater against pollution and deterioration. Off. J. Eur. Union L 2006, 327:19-31.
15. EC Guidance Document on the Assessment of the Relevance of Metabolites in Groundwater of Substances Regulated under Council Directive 91/414/EEC. Sanco/221/2000 -rev.10-final, 25 February 2003 2003.
16. EC Guidance Document on Aquatic Ecotoxicology in the Context of the Directive 91/414/EEC. Sanco/3268/2001 rev.4 (Final) 2002, 17 October 2002.
17. EC Directive 2000/60/EC of the European parliament and of the council of 23 October 2000 establishing a framework for community action in the field of water policy. Off. J. Eur. Union L 2000, 327:1-71.
18. EC Council directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Off. J. Eur. Union L 1998, 330:32-54.
19. EC Council directive of 15 July 1991 concerning the placing of plant protection products on the market, 91/414/EEC. Off. J. Eur. Union L 1991, 230:1-194.
20. EC Council directive 80/778/EEC of 15 July 1980 related to the quality of water intended for human consumption. Off. J. Eur. Union L 1980, 229:11-29.
21. ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.8: Characterisation of Dose [Concentration]-Response for Human Health 2012, 1-186.
22. ECETOC Effects of Chemical Co-exposures at Doses Relevant for Human Safety Assessments 2012, Technical Report No. 115, 26 July 2012.
23. EFSA Scientific opinion - guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters. EFSA Panel on Plant Protection Products and their Residues (PPR), European Food Safety Authority (EFSA), Parma, Italy. EFSA J. 2013, 11(7):3290.
24. EFSA Scientific opinion on evaluation of the toxicological relevance of pesticide metabolites for dietary risk assessment. EFSA Panel on Plant Protection Products and their Residues (PPR), European Food Safety Authority (EFSA), Parma, Italy. EFSA J. 2012, 10(7):2799.
25. EFSA Scientific opinion: exploring options for providing preliminary advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). European Food Safety Authority (EFSA) Scientific Committee, Parma, Italy. EFSA J. 2012, 10(7):2750.
26. EFSA Scientific opinion: guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. European Food Safety Authority (EFSA) Scientific Committee, Parma, Italy. EFSA J. 2012, 10(3):2579.
27. EPA National Primary Drinking Water Regulations 2009, United States Environmental Protection Agency, EPA 816-F-09-004; download available at:. http://water.epa.gov/drink/contaminants/upload/mcl-2.pdf.
28. Feigenbaum A., Pinalli R., Giannetto M., Barlow S. Reliability of the TTC approach: learning from inclusion of pesticide active substances in the supporting database. Food Chem. Toxicol. 2015, 75:24-38.
29. FERA ADesk Study on Pesticide Metabolites, Degradation and Reaction Products to Inform the Inspectorate's Position on Monitoring Requirements 2010, The Food and Environment Research Agency, York.
30. FOCUS Assessing Potential for Movement of Active Substances and Their Metabolites to Ground Water in the EU. Report of the FOCUS Ground Water Work Group 2009, 604. EC Document Reference Sanco/13144/2010 version 1.
31. Hamilton D.J., Ambrus A., Dieterle R.M., Felsot A.S., Harris C.A., Holland P.T., Katayama A., Krihara N., Linders J., Unsworth J., Wong S.S. Regulatory limits for pesticide residues in water. IUPAC Technical Report. Pure Appl. Chem. 2003, 75:1123-1155.
32. Happel O., Mertineit S., Brauch H.-J., Wunderlich H.-G., Dölling E., Grummt T., Kramer M., Schmidt C.K. Abschlussbericht zum Forschungsvorhaben: Entstehung, Vorhersage und Bewertung von Transformationsprodukten anthropogener Spurenstoffe bei der oxidativen Trinkwasseraufbereitung am Fallbeispiel PSM-Metaboliten. Final project report 2013, Umweltbundesamt Deutschland, RheinEnergie AG, DVGW Technologiezentrum Wasser, June 2013.
33. HSE Applicability of Thresholds of Toxicological Concern in the Dietary Risk Assessment of Metabolites, Degradation and Reaction Products of Pesticides 2009, Scientific/Technical Report submitted to EFSA, prepared by Brown H, Carter J, Dewhurst I, Stephenson C, Tessier S. Project ID: CFP/EFSA/PPR/2008/01), accepted for Publication on 27 November 2009, Health and Safety Executive, UK.
34. Kalkhof H., Herzler M., Stahlmann R., Gundert-Remy U. Threshold of toxicological concern values for non-genotoxic effects in industrial chemicals: re-evaluation of the Cramer classification. Arch. Toxicol 2012, 86:17-25.
35. Kroes R., Renwick A.G., Cheeseman M., Kleiner J., Mangelsdorf I., Piersma A., Schilter B., Schlatter J., van Schothorst F., Vos J.G., Wurtzen G. Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem. Toxicol. 2004, 42:65-83.
36. Leeman W.R., Krul L., Houben G.F. Complex mixtures: relevance of combined exposure to substances at low dose levels. Food Chem. Toxicol. 2013, 58:141-148.
37. Laufersweiler M., Gadagbui B., Baskerville-Abraham I.M., Maier A., Willis A., Scialli A.R., Carr G.J., Felter S.P., Blackburn K., Daston G. Correlation of chemical structure with reproductive and developmental toxicity as it relates to the use of the threshold of toxicological concern. Regul. Toxicol. Pharmacol. 2012, 62:160-182.
38. LUBW Grundwasserüberwachungsprogramm - Ergebnisse der Beprobung 2013. Reihe Grundwasserschutz Bd. 49 2014, Landesanstalt für Umwelt, Messungen und Naturschutz, Baden-Württemberg.
39. Melching-Kollmuß S., Dekant W., Kalberlah F. Application of the ''threshold of toxicological concern" to derive tolerable concentrations of ''non-relevant metabolites" formed from plant protection products in ground and drinking water. Regul. Toxicol. Pharmacol. 2010, 56:126-134.
40. Michalski B., Stein B., Niemann L., Pfeil R., Fischer R. Assessment of the relevance of metabolites in groundwater in the context of national approval procedures of plant protection products. Nachrichtenbl. Deut. Pflanzenschutzd. 2004, 56:53-59.
41. Ministère des Affaires Sociales, de la Santé et des Droits des Femmes Subject: Métabolites de pesticides dans l'eau destinée à la consommation humaine 2014, Letter from 22 Sept 2014, DGS/EA4 no. 318, addressed to Union des Industries de la Protection des Plantes.
42. Ministère de la Santé et des Solidarités Arrêté du 11 janvier 2007 relatif aux limites et références de qualité des eaux brutes et des eaux destinées à la consommation humaine mentionnées aux articles R. 1321-2, R. 1321-3, R. 1321-7 et R. 1321-38 du code de la santé publique. J.Off. Répub. Fr. 2007, Texte 17 sur 121.
43. Munro I.C., Ford R.A., Kennepohl E., Sprenger J.G. Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food Chem. Toxicol. 1996, 34:829-867.
44. NHMRC, NRMMC Australian Drinking Water Guidelines Paper 6, Version 2.0 Updated Dec 2013, National Water Quality Management Strategy 2011, National Health and Medical Research Council, National Resource Management Ministerial Council, Commonwealth of Australia, Canberra.
45. Price P.S., Hollnagel H.M., Zabik J.M. Characterizing the noncancer toxicity of mixtures using concepts from the TTC and quantitative models of uncertainty in mixture toxicity. Risk Anal. 2009, 29:1534-1548.
46. van Ravenzwaay B., Dammann M., Buesen R., Flick B., Schneider S. The threshold of toxicological concern for prenatal developmental toxicity in rabbits and a comparison to TTC values in rats. Regul. Toxicol. Pharmacol. 2012, 64:1-8.
47. van Ravenzwaay B., Damman M., Buesen R., Schneider S. The threshold of toxicological concern for prenatal developmental toxicity. Regul. Toxicol. Pharmacol. 2011, 59:81-90.
48. Republik Österreich Trinkwasserverordnung - TWV. Bundesgesetzblatt für die Republik Österreich, 304. Verordnung, 21 August 2001, Teil II 2001, 1802-1822.
49. Republik Österreich Qualitätszielverordnung Chemie Grundwasser - QZV Chemie GW, Bundesgesetzblatt für die Republik Österreich, 98. Verordnung, 29 März 2010, Teil II 2010.
50. Schmidt C.K., Brauch H.-J. N,N-Dimethylsulfamide as precursor for N-Nitrosodimethylamine (NDMA) formation upon ozonation and its fate during drinking water treatment. Environ. Sci. Technol. 2008, 42:6340-6346.
51. Staatsblad Besluit van 23 mei 2011, houdende bepalingen inzake de productie en distributie van drinkwater en de organisatie van de openbare drinkwatervoorziening (Drinkwaterbesluit) 2011.
52. Staatscourant Regeling van de Staatssecretaris van Infrastructuur en Milieu van 14 juni 2011, nr. BJZ2011046947 houdende nadere regels met betrekking tot enige onderwerpen inzake de voorziening van drinkwater, warm tapwater en huishoudwater (Drinkwaterregeling) 2011, Nr. 10842, 27 June 2011.
53. Statutory Instruments The Water Supply Regulations 2010 2010, Water, England and Wales, 2010 No. 991, The Stationery Office Limited.
54. Umweltbundesamt Trinkwasserhygienische Bewertung stoffrechtlich nicht relevanter Metaboliten von Wirkstoffen aus Pflanzenschutzmitteln im Trinkwasser. Empfehlung des Umweltbundesamtes nach Anhörung der Trinkwasserkommission des Bundesministeriums für Gesundheit beim Umweltbundesamt. Bundesgesundheitsbl. Gesundheitsforsch. Gesundheitsschutz 2008, 51:797-801.
55. Umweltbundesamt - Austria GZÜV-Sondermessprogramm Pestizide und Metaboliten 2010 - Endbericht 2011, Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft/Sektion VII/Nationale Wasserwirtschaft in Zusammenarbeit mit dem Umweltbundesamt, Wien, Austria.
56. Umweltbundesamt Gesundheitliche Orientierungswerte (GOW) für nicht relevante Metaboliten (nrM) von Wirkstoffen aus Pflanzenschutzmitteln (PSM) 2012, Fortschreibungsstand: 31.01.2012. Online publication:. http://www.umweltdaten.de/wasser/themen/trinkwassertoxikologie/tabelle_gow_nrm.pdf.
57. Voet van der H., Boer de W.J., Kruisselbrink J.W., Goedhart P.W., Heijden van der G.W.A.M., Kennedy M.C., Boon P.E., Klaveren van J.D. The MCRA model for probabilistic single-compound and cumulative risk assessment of pesticides. Food Chem. Toxicol. 2015, 79:5-12.
58. WHO Report on Regulations and Standards for Drinking Water Quality 2013, Draft 12, Nov 2013. Compiled by David Drury, UK. Available for download at. http://www.who.int/water_sanitation_health/Draft_RegScan_May_2014.pdf.
59. WHO Guidelines for Drinking-water Quality 2011, World Health Organization, Geneva. fourth ed.