Trigger values for active substances, relevant and non-relevant metabolites in Ground Water/ Drinking water

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1 Environmental Risk Assessment for Plant Protection Products 2017: Scientific Basis for the Best Trigger Trigger values for active substances, relevant and non-relevant metabolites in Ground Water/ Drinking water Dr Chris Leake, Environmental Safety Manager, Bayer Crop Science Division Dr Volker Laabs & Dr Stephanie Melching-Kollmuß, BASF Dr Dick Lewis, Syngenta On behalf of ECPA Non-relevant metabolite group

2 Content Introduction and definitions Guidance Document on assessment of relevance and trigger values Current water regulations in the EU - pseudo trigger values Proposal for scientifically based trigger values Summary 2 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

3 Introduction- definitions Definition of a metabolite: the term is used for all reaction or breakdown products of an active substance of a plant protection product, which are formed in the environment after the application, be it by biotic (microbials, other taxa) or abiotic processes (hydrolysis, photolysis). The terms metabolite, breakdown product and degradation product are used interchangeably. Trigger values used for identification: Therefore, as a minimum, degradation products must be characterised and identified by the notifiers to the extent that is technically feasible and their relevance must be assessed [if shown to exceed 0.1µg/L], if one of the following conditions applies: A. Metabolites, which account for more than 10 % of the amount of active substance added in soil at any time during the studies; or B. which account for more than 5 % of the amount of active substance added in soil in at least two sequential measurements during the studies; or C. for which at the end of soil degradation studies the maximum of formation is not yet reached. Moreover, all metabolites found in lysimeter studies at annual average concentrations exceeding 0.1 µg/l in the leachate should be identified and subject to further assessment. 3 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd

4 Introduction- definitions Legislation implies that there are "relevant" and "non-relevant" metabolites Active substances and relevant metabolites are referred to in the drinking water directive (98/83/EC), also in the groundwater directive. Neither of these directives defines the term relevant metabolite. Non-relevant metabolites are compounds which do not have pesticidal properties and therefore should be regulated similarly to other chemicals, and differently from pesticides and their relevant metabolites. Regulation 1107/2009 defines a relevant metabolite as follows: - it shows intrinsic properties comparable to parent (biological activity) OR - it shows comparable or higher risk for organisms OR - it has toxicological properties, which are considered unacceptable 4 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

5 Introduction- definitions According to the Sanco guidance (221/2000)*, a non-relevant metabolite in groundwater needs to fulfil: Biological activity clearly less than 50% of parent Not genotoxic Parent is not a carcinogen of category 1 or 2 (R45) If parent is classified as - toxic or very toxic, - reprotox cat. 1 / 2 / 3 (R60, R61, R62, or R63) - carcinogen cat. 3 metabolite has to be tested and shown to be not classified as one of the above. Otherwise: it is a relevant metabolite According to the Sanco guidance (221/2000)*, Relevant metabolite: a metabolite for which there is reason to assume that it has comparable intrinsic properties as the active substance in terms of its biological target activity, or that it has certain toxicological properties that are considered severe and unacceptable with regard to the decision-making criteria described in the text. Such a metabolite is therefore treated like the parent active substance in the assessment. Where such a metabolite exceeds the maximum permissible concentration (0.1 μg/l) for groundwater, a non-inclusion decision would be triggered at Community level for the active substance or a non authorization decision would be triggered at national level for specific uses of products containing that substance; 5 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017 * Guidance Document on the Assessment of the Relevance of Metabolites in Groundwater of Substances regulated under Council Directive 91/414/EC, Sanco/221/2000, rev. 10, 25 Feb 2003.

6 Introduction- definitions According to the Sanco guidance (221/2000)*: Metabolite of no concern: A metabolite which meets the criteria outlined in Step 1 of Part 4 below and is therefore deemed to be not relevant in the assessment according to Annex VI, point C of Directive 91/414/EEC. According to the Sanco guidance (221/2000)*, Non-relevant metabolite: a metabolite which does not meet the criteria provided for relevant metabolites and metabolites of no concern. A non-relevant metabolite may be subject, on a caseby-case basis, to an individual groundwater limit concentration, as outlined in detail in this document. 6 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

7 Guidance Document Sanco guidance 221/ Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

8 Guidance Document Sanco guidance 221/2000 Guidance (SANCO/221/2000 rev.10. final) is the valid document 8 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

9 Guidance Document Sanco guidance 221/2000 Tiered approach 1. Exclude metabolites of no concern (e.g. CO2, substances present at much higher levels in GW naturally) 2. Identify all metabolites for which PECgw >0.1 µg/l (FOCUS modelling) 3. Hazard assessment (3 steps) 4. Exposure assessment (threshold of concern: 0.02 µg/kg body weight/day, all routes of exposure) 5. Refinement and full risk assessment 6. Decision on relevance 9 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

10 From ground water estimations for product approval to the Drinking Water Directive Ground water concentrations (Predicted Environmental Concentrations PECgw) are calculated at 1m soil depth based on 9 scenarios, combining weather, soil and cropping data, collectively representing EU agriculture and using 4 simulation models (MACRO, PEARL, PELMO and PRZM) in a tiered approach with the protection goal of "safeguarding the drinking water function of the groundwater" The assessments are therefore conservative for what is taken for drinking water due to additional dilution factors from 1m soil depth to the abstraction point from the aquifer. Soil water at 1 m depth Groundwater body Raw water for drinking water 10 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

11 From ground water estimations for product approval to the Drinking Water Directive Normally there are also untreated fields, natural areas such as woodlands or pasture from which rainwater will flow into the tapped aquifer. Water companies claim that they should be able to abstract water from any type of aquifer and use it untreated as drinking water in reality they have to undertake at least basic treatment processes for microbial safety reasons. For pesticides a general limit (not health-based but precautionary ) is set at 0.1µg/L except where the health based limit is lower 11 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

12 Guidance Document Sanco guidance 221/2000 DG Sanco Guidance gives the following testing guidance: For metabolites classified as non-relevant, the following threshold values for PECGW are defined in the guidance document: 0.75 μg/l: The active substance is eligible for registration 0.75 to 10 µg/l: Refined risk assessment needed in order to be eligible for registration (expert judgement based on existing toxicological data: definition of acceptable limit in groundwater ) >10 µg/l: The substance must be carefully evaluated, considering a high protection level for groundwater (precautionary principles & positive risk assessment: registration and definition of acceptable limit in groundwater ) Being common chemical substances, without specific pesticidal activity, individual and toxicology-based limit values for drinking and groundwater would be justified for non-relevant metabolites. 12 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017 Based on threshold of toxicological concern (TTC) for chemicals of concern (US-FDA interpretation, historical) Toxicological testing is needed to identify a safe level to do risk assessment Pragmatic upper limit value, in analogy to the one of chlorinated aliphatic hydrocarbons in EU DW Dir. 12

13 The 10µg/L trigger- where does it come from? The guidance states: This limit value of 10µg/L is selected for pragmatic reasons. It is also the current limit value defined in the Drinking Water Directive for chlorinated aliphatic hydrocarbons such as trichloroethene. Some degradation products of pesticides may belong into this chemical category. Note that some other products may also belong to other defined categories in Drinking Water Directive and are, therefore, subject to a different level. Where actual or predicted concentrations of a non-relevant metabolite in groundwater exceed 10 μg/l, no general guidance can be provided in the context of this document. As outlined in the introduction, regulatory decisions must maintain a high level of protection for groundwater. Therefore, it is necessary to carefully evaluate case by case, whether the requirements of Article 5 (1) of the Directive are still fulfilled and the active substance can be included in Annex I to the Directive. Such an assessment must consider the overall profile and use pattern of the substance and it must be based on strict precaution. Conclusion 10 µg/l is not a fixed upper limit. Substance specific values based on data are allowed. 13 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

14 Drinking Water Directive Parametric values are given in the drinking water directive (98/83/EC) on an individual compound basis: Examples: lead 10µg/L, copper 2 µg/l, benzene 1 µg/l, arsenic 10 µg/l, cyanide 50 µg/l, trihalomethanes - total 100 µg/l, tetrachloroethane and trichloroethane 10 µg/l. Values are based on WHO methodology the same approach can be taken for non-relevant metabolites. For pesticide metabolites a lot of toxicological information is obtained. 14 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

15 Current water regulations in the EU Non-relevant metabolites are not explicitly regulated in the EU: Dir. 98/83/EC, drinking water Dir. 2006/118/EC, groundwater Laabs et al., 2015, Regulatory Toxicology and Pharmacology 73 p Heterogenic national regulation of non relevant-metabolites in different EU countries AT, DE: legally non-binding, health - related indication values DK: all metabolites relevant UK: specific limits based on risk FR: general limit value for raw water, Vmax values based on substance specific values are calculated when needed NL: legal limit for surface water used for drinking water abstraction 15 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017 Existing drinking water thresholds for non-relevant metabolites 15

16 Proposal for scientifically based trigger values Deriving health-oriented limit values A threshold of toxicological concern (TTC) value is a human exposure threshold value for a chemical of unknown toxicity, below which there is no appreciable risk to health following oral exposure for a life-time Application of the TTC approach requires knowledge of the structure of the chemical and adequate human exposure estimates Specific structures are excluded from the applicability of the TTC concept The use of the TTC principle eliminates the necessity of extensive toxicity testing and safety evaluations, when human intakes of a chemical are below a certain level of concern The TTC values are considered to cover* life-long exposure reprotox/developmental effects adverse effects with endocrine disruptive mode of action (except for steroides) * EFSA, Scientific Opinion on exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). EFSA Scientific Committee. 16 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd

17 Proposal for scientifically based trigger values Defining structural substance classes Cramer classes (evaluated for 613 chemical substances with tox data) Cramer I: simple structures, efficiently metabolised, low potential for toxicity (137) Cramer II: between Cramer I and III (28) Cramer III: structural features that may suggest toxicity (448) Principle of threshold value determination: The lowest NOAEL from a number of different studies was selected for each chemical and the cumulative percentage plotted within each structure class. 17 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

18 Toxic Potential Proposal for scientifically based trigger values Application to class of non relevant metabolites Summary: Process to derive TTC values for non-relevant metabolites Dekant et al., 2010 Melching-Kollmuß et al., 2010 Munro et al., 1996 Van Ravenzwaay et al., 2011 Statistical data basis NOAELs >600 Substances (non genotoxic, no OPs) Cramer class I Cramer class II Cramer class III 5 th perc. Safety factor : 100 TTC value is also safe for - pregnant women - children (reprotox data evaluation; conservative assumptions) WHO method for deriving drinking water guideline values (WHO, 2011): ADI * 10% (allocation for DW) * 60 kg / 2 L (DW consumed per day) = 4.5 µg/l 18 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017 Acceptable daily intake ADI: 1.5 µg/kg/d (= 90 µg/person/d) 18

19 Proposal for scientifically based trigger values Defining TTCs for substance classes Based on the Cramer class NOAEL distribution, the 5 th percentile NOAEL was selected and divided by a safety factor of 100: This value is then converted into a daily intake per person. Chronic NOAELs have been used in most cases (an additional safety factor of 3 was applied in case of subchronic NOAELs) The TTCs only apply to substances with defined chemical structures, for which there is no evidence of genotoxic carcinogenicity and no structural alerts for genotoxicity. 19 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

20 Proposal for scientifically based trigger values Defining TTC-based water limits Thresholds of Toxicological Concern (TTCs) TTC value [µg/person/d] TTC value for water* [µg/l] High concern Cramer class III Cramer class II Cramer class I ** * Calculation basis: person of 60 kg, consumption of 2 L water/day (= WHO); 10% contribution of drinking water to ADI ** 100% contribution of drinking water to ADI TTC value used in SANCO 221/ Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd

21 Proposal for scientifically based trigger values Using a refined TTC concept In case that a general threshold for non-relevant metabolites must be established OR no data is available for a non-relevant metabolite (relevance tested, non genotoxic) an adapted TTC value shall be used, based on the substance properties of the group of non-relevant metabolites (per definition): 10% ADI 4.5 µg/l or 20% ADI 9.0 µg/l (0.9 µg/l for organophosphates/carbamates) Use of TTC is consistent with other regulations in the EU and globally, e.g. for REACH Guidance (Appendix R.7-1) alternatively, a toxicological threshold may also be based on the statistical analysis of the toxicological data of a broad range of structurally-related... chemicals... Food contact materials (EFSA, US-FDA) Flavourings and food additives (EFSA, FAO/WHO) Pharmaceuticals genotoxic impurities (EMEA) 21 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd

22 ECPA Position Test of TTC concept Situation for active substances & metabolites TTC values are conservative: Laabs et al., 2015, Regulatory Toxicology and Pharmacology 73 p WHO DW guidance values for AIs (TTC: µg/l) all (375 AIs*) Min: 0.2 µg/l EU approved (264 AIs*) Min: 0.6 µg/l EU appr. & non-hazard (195 AIs*) Min: 1.95 µg/l WHO DW guidance values for nonrelevant metabolites (TTC: 4.5 µg/l) 56 nr-metabolites (from 35 AIs) Minimum: 10.5 µg/l 10 th perc: 106 µg/l Median: 1025 µg/l * EU data base: 22 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017 Drinking Water Guidance Value [µg L -1 ] All active ingredients (AIs) EU approved AIs EU approved AIs, non-hazardous non-relevant metabolites Figure: Drinking water guidance values (WHO standard methodology, 10% ADI allocation) B 22

23 Summary ECPA proposal for regulation of non-relevant metabolites. Concentration (µg/l) healthbased Limit for AIs/relevant metabolites in DW/GW German health values TTC for substances of concern used in SANCO Pragmatic upper threshold for nr-metabolites in SANCO ECPA Proposal: Generic TTC for group of nr-metabolites If needed Substancespecific: usually >10 µg/l hence the current guidance document on non-relevant metabolites is very protective. 23 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd

24 Summary Conclusions & Research Needs For active substances and relevant metabolites the trigger value of 0.1 µg/l has been shown to be a precautionary value. A TTC value of 4.5 µg/l can be established for non-relevant metabolites, which have been classified as non genotoxic : No other substance properties* need to be tested (* for organophosphates/carbamates, a TTC value of 0.9 µg/l applies) If the concentration in ground or drinking water is expected to exceed 4.5 µg/l (could even be 9 µg/l) for a non-relevant metabolite in reality: Further assessment and/or toxicological tests would be needed to derive a substance-specific ADI definition of a health-based, individual limit value in water (e.g. via WHO) Research is needed to establish a reliable and realistic assessment to predict / study the behaviour of all substances during drinking water treatment (i.e. ozonation, chlorination) (Reg. 1107/2009, Art. 4.3.b) further evaluate vulnerable pedo-climatic situations for non-relevant metabolite leaching 24 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd

25 Summary For active substances and relevant metabolites the trigger values for groundwater & drinking water are very precautionary and highly protective. The existing definition in Reg. 1107/2009 and assessment methodology in the Sanco Guidance Document (Sanco/221/2000) when used as the basis for defining the relevance and trigger values of metabolites throughout the EU legislation is also very precautionary and even more highly protective. Non-relevant metabolites are substances without pesticidal properties regulation like other general anthropogenic chemicals should apply i.e. specific, health-based limit (trigger) values in ground- and drinking water A consistent definition, trigger setting and regulation of non-relevant metabolites in ground and drinking water in the EU is desirable, as (i) all stakeholders gain legal clarity definition, assessment criteria, level of consumer protection (ii) water companies would have clear targets and could reduce unnecessary treatment costs (iii) crop protection industry achieves planning security to develop new and innovative substances for the EU market (iv) harmonized availability of crop protection products to farmers in the EU 25 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd

26 Thank you for your attention References 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. Regulatory Toxicology and Pharmacology 56: Laabs, V., Leake, C., Botham, P., and Melching-Kollmuß, S 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 73 : 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. Regulatory Toxicology and Pharmacology 56 : 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. Toxicolcology. 34: Ravenzwaay, B. van, Damman, M., Buesen, R., Schneider, S The threshold of toxicological concern for prenatal developmental toxicity. Regulatory Toxicology and Pharmacology. 59: Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

27 Backup Applicability of TTC concept Substances excluded from TTC High potency carcinogens (aflatoxin-like, azoxy- or N-nitroso compounds) Inorganic substances Metals Proteins Substances known or predicted to bioaccumulate Substances with structures not adequately represented in original databases (nanomaterials, radioactive substances) Substances likely to have potential for local effects (e.g. corrosiveness, acidity) 27 Scientific basis for the best trigger ECPA Rothamsted UK March 22 nd 2017

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