1. Groundwater Watch list «draft concept report»
32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Groundwater Watch list «draft concept report»
Rüdiger Wolter – Germany
Ronald Kozel – Switzerland
and
group of volunteers:
Benjamin Lopez – France (French Geological Service); Dennis Lemke – European Chemicals Commission; Volker Laabs and Dieter Schaefer - European Crop Protection Agency; Elisa Vargas Amelin - EU Commission; Emanuele Ferretti – Italy; Jacqueline Claessens – Netherlands ; Johannes Grath – Austria; Jonathan Smith - (CONCAWE); Ralph Eppinger – Flemish EA; Francis Delloye - Belgium, Wallonia; Rob Ward - UK BGS; Tim Besien - England EA; Wilko Verweij – Netherlands; Dan Lapworth – UK
Malta (MT), April 2017

2. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
What has already been done:
Watch list process launched by WG groundwater (Brussels) April 2015ü
Meeting group of volunteers (Berne)  1st draft 8./ ü
Discussion at WG groundwater plenary (Luxemburg) / ü
Summary report for SCG and Approval 9./ ü
Discussion at WG groundwater plenary (Amersfoort) / ü
Meeting group of volunteers (Vienna) 23./ ü
Meeting with NORMAN-working group (Paris) 27./ ü
Discussion at WG Groundwater plenary (Bratislava) 25./ ü
Tests of Column I, II and III procedure and adaptation Feb. 2017ü
Meeting group of volunteers (Paris) ü
Amendments and draft review April 2017ü

3. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
What has to be done:
Presentation and discussion (Malta) April 2017
Finalisation of GWWL methodology June 2017
Preparation of a second pilot study (PFCs) Mai 2017
Identification of organisation carrying out data collection June 2017
Start of first data collection
Identification of first candidates for watch list end of 2018
Support to EC review of Annexes I and II of GWD

4. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Group of Volunteers Meeting in Paris ( )
organised by Benjamin Lopez at BRGM
Discussion based on version 8.3 of draft concept report
Comments received from Ralf Eppinger, Francis Delloye, Kris von Den Belt and Christoph Leitner (COM) were integrated
Further comments on version 8.3 have been received from Dieter Schaefer, Volker Laabs (European Crop Protection Association) and Dennis Lemke, (CEFIC) and discussed
Comments received on version 8.5+ from Rob Ward (27/02/2017)
Discussion focussed on
Feedback to Draft 8.3 and 8.5+ of the Watch List Concept and
Results of test runs of the ranking procedure (Monitoring – Leaching Potential – Hazard)

5. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Outcome Paris meeting: Proposed and agreed amendments
New title: Groundwater Watch List (GWWL) - Concept and Methodology [old: Method to select substances for a Groundwater Watch List (GWWL) - Concept Paper -]
Chapter 1.3 (Purpose and scope of this report): The sentence: “Proposing a procedure to determine substances which should be included in the candidate list and finally in Annex I or II of the GWD” was skipped.
Chapter 2.2 (Purpose and scope of the GWWL): The sentence: “Create a candidate list for Annex I and II for the GWD” was skipped and replaced by “Provide information to support future European Commission review of Annexes I and II of the GWD”.
Suggestion: New text on “What GWWL process is NOT”
The Watch List should comprise only a limited number of substances or groups of substances.

6. Purpose of the watch list?
32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Purpose of the watch list?
(amended version)
Identify new/emerging substances which have the potential to cause a failure of a WFD objective, based on new information;
Assist MS in selecting substances to improve groundwater monitoring programs;
Provide information to support future European Commission review of Annexes I and II of the GWD.

7. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
The GWWL is not: (text integrated in version 9.3)
A long list of substances that is generated by the substance prioritization process described in Chapter 3 (methodology), but rather a smaller subset (for example n=20) of compounds decided on through the prioritization process;
A list of substances that will go automatically for consideration under Annex I and II. There will, by definition, be inadequate data for this on substances on the GWWL;
A permanent list of substances. The GWWL will be reviewed periodically and substances can be deselected based on the prioritization process outlined in this paper;
Meant as a ‘blacklist’ of substances which are of proven high concern for groundwater in the EU. The GWWL monitoring data will be available for use in a later and separate process for an EU-wide risk assessment.

8. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Further amendments
Transparency of the process: the development of the process and the implementation of the process shall be transparent (which data are used, which criteria are applied, methodology behind ….)
Quality requirements: in principle sufficiently covered in the draft, but more clarity in case there is lack of data e.g. for column II criteria like DT50, Koc, ….
Proper use of terms like "harm", "risk", … etc. in the text
The concept should comprise a deselection mechanism  No need to define a de-selection process now. This will be done later once a watch list is operating and the volunteer group has more experience of how the process is working. Substances will be deleted from the list, when they are put in Annex I or II or when EC decides not to regulate a substance.

9. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Procedure after Paris meeting
Circulation of revised version to the watch list drafting group - RK and RW integrate the amendments; input from drafting group members th March 2017ü
Comments and feedback by drafting group th March 2017ü
Updated Version 9.3 uploaded on CIRCABC rd April 2017ü
Many thanks for their important support to:
Benjamin Lopez, Dan Lapworth, Dennis Lemke, Volker Laabs, Dieter Schäfer, Johannes Grath

10. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Amended Process diagram according to discussion in Paris
Groundwater Watch list process
Prioritisation based on existing monitoring data
(column I)
Criteria: presence in GW
Output: ranked list I
Prioritisation based on exposure (column II)
Criteria: theoretical groundwater leaching potential and extent of potential environmental exposure
Output: ranked list II
All substances
Substances with groundwater leaching potential
Prioritisation based on hazard
(column III)
Criteria: toxicological or ecotoxicological hazard
Output: ranked list III
All substances except Annex I or II substances
List of substances having the proved and/or theoretical capacity to reach GW
Groundwater Watch List
GWWL
List of substances posing a risk or potential risk to GW bodies
List facilitating the Annex I + II process
Base for revision of Annex I and II lists
data available
Sufficient
monitoring
Watch list monitoring

11. Column I Prioritisation based on existing monitoring data
- Ranking procedure as presented in Bratislava
Indicators
Sub-score
Score “Monitoring”
A) Frequency of observations with concentrations > LOQ
= value as a decimal number rounded to two decimals
Value between 0 and 1
= (A + B + C) / 3
B) Number of countries with concentrations > LOQ
0 country = 0
1 countries = 0.10
>=2 countries = 0.20
>=5 countries = 0.50
>=10 countries = 1
C) Number of sites with concentrations > LOQ
0 site = 0
1 sites = 0.10
>=2 sites = 0.20
>=5 sites = 0.50
>=10 sites = 1
Score “Monitoring” = [(Score FQ) + (Score N°MS) + (Score N° Sites)] / 3

12. A) Frequency of observations with concentrations > LOQ
32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
A) Frequency of observations with concentrations > LOQ
A) Frequency of observations with concentrations > LOQ
A small number of sites analysed may lead to a high frequency
For micropollutants the frequency of findings is generally very low
Might be a misleading parameter because it is not known whether a substance is applied in the catchment of a sampling site.
This parameter was skipped

13. Comparison of results of different ranking procedures
Common Name
Ranking
((A+B+C)/3) Score
((A+B*+C)/3) Score
((B*+C)/2) Score
Carbamazepine 1
0,710
1,000
Sulfamethoxazole 3
0,517 2
0,617
0,900
Ibuprofen 5
0,507 4
0,540
0,800
Clofibric Acid
0,510 6
0,750
Diclofenac
0,504 7
Sulfadiazine 21
0,402 8
0,469
0,700
Clarithromycin 18
0,403 12
0,437
0,650
Fenofibric Acid 14
0,407 11
0,441
Paracetamol
0,482
0,515 9
Phenazon
0,409 10
0,443
Tramadol
0,427
0,460
Atenolol 22
0,600
Erythromycin 20 13
Gemfibrozil 24
0,401
Hydrochlorothiazide 15 17
iopamidol
0,408 16
Ketoprofen 23
Metformin
0,418
Metoprolol 25 19
Primidon
0,419
Propyphenazon
Sotalol
0,406
Sulfadimidine
Sulfamethazine
0,404
4-Formylaminoantipyrin 27
0,384
0,550
Bezafibrate 42
0,368 26

14. Column I: Amended ranking procedure
Indicators
Sub-score
Monitoring score
A) Number of countries with concentrations > LOQ (Score N°PC)
(Values between 0 and 1)
no country = 0.0
1 country = 0.2
2 countries = 0.4
3 countries = 0.6
4 countries = 0.8
5 or more countries = 1
[ (Score N°PC) + (Score N° sites)] / 2
Value between 0 and 1
B) Number of sites with concentrations > LOQ (Score N° sites)
no site = 0.0
sites = 0.1
sites = 0.2
sites = 0.3
16 – 20 sites = 0.4
21 – 25 sites = 0.5
26 – 30 sites = 0.6
31 – 35 sites = 0.7
36 – 40 sites = 0.8
41 – 45 sites = 0.9
> 45 sites = 1.0
Monitoring score = [ (Score N°PC) + (Score N° sites)] / 2

15. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Ranking according to a theoretical groundwater leaching potential (Column II)
Identifies the ability of a substance to reach groundwater based on the properties of that substance
The mobility of a substance which is expressed by the solubility in water and the disability to be adsorbed to organic matter and (clay) minerals (the latter can be expressed by the logKOW (logP) or logD (grouping logKOW and log pKa)); and
The persistence of the substance expressed by the half-life (DT50) depending on the physico-chemical conditions, as well as bioaccumulation and toxicity (PBT).
+ the amount of a substance released to the environment
+ ”type of exposure” (closed processes - e.g. with no intentional release to the environment - applied directly to the environment - i.e. air, soil and water)

16. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Column II: substances that have theoretically the potential to reach GW
General procedure : Step1 “leaching potential” and Step2 “use pattern”
Step: classical point system procedure

17. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Open question remains concerning the mobility assessment for polar and charged compounds
First proposal: mention in the GW watch list concept paper the need for a specific approach for polar and charged compounds that could consist in a ranking based on the radicals of the molecules
Agreement: we need a simple and comprehensive mobility assessment method for polar and charged compounds
Proposed solution: approach should use the Soil Kd value, if available, to quantify sorption of polar and charged compounds
To be furthermore discussed in the drafting group

18. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Column II: substances that have theoretically the potential to reach GW
Step 2 of the column II:
amount of a substance released to the environment
how it gets to the groundwater table (pathways into the environment / to the groundwater table)
Very important criteria for current assessment but
Unlike chemical properties, it can evolve over time… (continuous activity)
Criteria
Indicators
Cut off values and sub-score
Score
Use
Use pattern
Used in the environment = 1.0
𝑆𝑐𝑜𝑟𝑒 “𝑈𝑠𝑒” = [(“𝑈𝑠𝑒 𝑝𝑎𝑡𝑡𝑒𝑟𝑛” 𝑠𝑐𝑜𝑟𝑒) + (“𝑉𝑜𝑙𝑢𝑚𝑒” 𝑠𝑐𝑜𝑟𝑒)] 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑓𝑖𝑙𝑙𝑒𝑑 “𝐼𝑛𝑑𝑖𝑐𝑎𝑡𝑜𝑟𝑠"
Wide dispersive use (diffuse sources and substances in urban wastewater) = 0.6
Intermediate use only = 0.3
Production volume (REACH)
Annual tonnage >1000t = 1.0
t = 0.75
t = 0.5
0.1 – t = 0.25
< 0.1t = 0.0
Specific use indicators for Pharmaceuticals? (Annual EU tonnage not available)

19. Column III: hazard ranking
Direct from NORMAN procedure - Valeria Dulio & Peter C. von der Ohe, NORMAN Prioritisation framework for emerging substances (2013)
Indicators
Value
Sub-score
Score “Hazard”
PBT/vPvB
Overall PBT/vPvB score = [(P + B + T) individual scores + (PBT/vPvB) score]/4
PBT: vP or P (1) + vB or B (1) + T+ or T (1) + vPvB or PBT (1) = 1
vPvBT+: vP or P (1) + vB or B (1) + T+ or T (1) + vPvB or PBT (1) = 1
vPvB: vP or P (1) + vB or B (1) + T+ or T (0) + vPvB or PBT (1) = 0.75
PB: vP or P (1) + vB or B (1) + T+ or T (0) + vPvB or PBT (0) = 0.5
PT+: vP or P (1) + vB or B (0) + T+ or T (1) + vPvB or PBT (0) = 0.5
Not PBT, not vPvB = 0
Value between 0 and 1
= [(PBT/vPvB) + (CMR) + ED)] / number of filled criteria
CMR
The CMR final score is derived as the highest value between the individual carcinogenicity, mutagenicity and reprotoxicity scores
CMR, category 1 = 1
CMR, category 2 = 0.75
CMR, category 3 = 0.5
Under examination = 0.5
Examined and info not suff. = 0.25
Not examined = 0.25
Examined and not classified = 0
Endocrine Disrupting effects
Proven ED = 1
Suspected ED = 0.5
Not proven ED = 0
Score “Hazard” = [(“PBT / vPvB” score) + (“CMR” score) + (“ED” score)] / number of filled “criteria”

20. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Column III: Run test 1 – NORMAN scoring process
Run test on Pharmaceuticals from the Pilot Study (285 individual names)
Pharmaceuticals that have been scored regarding their potential hazard AND
Pharmaceuticals ‘sufficiently monitored’ = analysed in 3 MS or more and quantified at least once => cut-off value to be elaborated
56 pharmaceuticals plotted (first 20 in diagram)

21. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
To be discussed:
In the frame of the watch list process, criteria have furthermore to be decided on the following questions:
Following which procedure ranked lists I and II are used for column III
Following which procedure substances have finally to be put into the Watch List based on ranked list III?
Which of the substances should be put on the Watch List, but cannot be analysed due to missing or insufficient analytical techniques? What to do with these substances?
Following which criteria substances should be put directly on the “List facilitating the Annex I and II process” (former “candidate list”) as sufficient data are already available?
Definition of "sufficient monitoring data" has to be elaborated
Which substances should not (yet) be put onto the Watch List?
Who will do the work??
Which substances are so hazardous, that they should be regulated immediately without waiting until sufficient findings (contamination) of groundwater are identified (in Watch List Monitoring). How to avoid contamination by these substances – strengthen the prevent and limit approach)?

22. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Next steps after Malta
Drafting group meeting in summer 2017 (open questions)
Discuss the effect of the parameters “amount of substance” and “type of exposure” that are not jet integrated in Column II (assessment of leaching potential).
Test of ranking procedure in Column I, II and III and global linkage
Preparation of a second pilot study on PFCs. Emanuele Ferretti has provided a list of substances from the PFC group, including CAS codes. Based on that, RW developed a template for data collection for the 2nd pilot study. This template shall be complemented by a short questionnaire concerning monitoring information - e.g. whether background stations or "worst case" stations were selected, etc.
The template and the questionnaire will be distributed to MS and PC
MS and PC are asked to fill in the template and the questionnaire and send it back to RW.
It has to be checked whether these data could be stored and managed under IPCHEM

23. 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta
Thank you for your attention !

24. (B) Number of countries with concentrations > LOQ
It should be sufficient if a substance is found in 5 or more countries to get the maximum value.

25. (C) Number of sites with concentrations > LOQ
The number of sites should be greater than 45 to get the maximum value of 1.00