Human & Environmental Risk Assessment Environmental Risk Assessment under HERA: Challenges and Solutions Kay Fox Cha

1. Human & Environmental Risk Assessment • Environmental Risk Assessment under HERA: Challenges and Solutions • Kay Fox • Chair of the HERA Environmental Task Force HERA at XXXI CED Kay Fox

2. Environment Task Force C. Poelloth, C. Arregui, J. Backmann - AISE I. Lopez Petresa C. Stevens Dow Corning G. Boeije P&G R. van Egmond Unilever H. Certa SASOL R. van Wijk Akzo Nobel R. Elsmore McBride T. Wind Henkel K. Fox Unilever A. AartsSolutia P. Masscheleyn P&G A. Berends Solvay P. Richner CIBA D. Calcinai Condea Augusta W. Schul BASF E. Cerbelaud Rhodia J. Steber Henkel V. Koch ClariantR. Toy Shell Chemicals HERA at XXXI CED Kay Fox

3. Intended for application in EUROPE HERA Environmental Risk Assessment based on Technical Guidance Document for New and Existing substances EUSES HERA at XXXI CED Kay Fox

4. Focus on chemical substances used primarily in Household detergent and cleaning products Domestic Emission On-Site Treatment Sewer Transport Primary Focus on the use and disposal of these substances Sewage Treatment River HERA at XXXI CED Kay Fox

5. Detergent exposure scenario for EUSES TGD • Begin with EUSES • Environment • Local • Regional • Predators exposed via the environment • Man exposed via the environment HERA at XXXI CED Kay Fox

6. Detergent exposure scenario for EUSES HERA HERA Effectively in HERA HERA • Wide dispersive use, Detergents (5, 9) • 100% of chemical to sewer (Local Use model) HERA at XXXI CED Kay Fox

7. Detergent exposure scenario for EUSES Contributions to Regional Environment from Local sources TGD Default HERA Production 0.3%0.3%(1.003)0 0 0.8% 0.8%0 0 max max Formulation Use 99%99%100%100% Bottom line - 100%, within volume determination error HERA at XXXI CED Kay Fox

8. Detergent exposure scenario for EUSES • To cover a “reasonable worst case”, TGD and EUSES assume that • the local wastewater treatment plant receives 4 times the average ingredient input • the Standard EU region receives 10% of the total European product consumption • HERA replaces these default assumptions with HERA default values based on measured product consumption and environmental monitoring data - the HERA Detergent Scenario. HERA at XXXI CED Kay Fox

9. Detergent exposure scenario for EUSES • Tiered Methodology • Begin with the HERA Detergent scenario • Accept all other EUSES Defaults • Replace selected defaults if necessary • Removal values in STP • Measured Kd values • Biodegradation rates in rivers, soil, etc. • Often need Chronic ecotoxicity data HERA at XXXI CED Kay Fox

10. Regional Environmental Concentration Standard EU Region 20 million people 10% of EU Production Production 200 km Formulation 200 km Use Release is based on Production Volume HERA at XXXI CED Kay Fox

11. STD. EU Region Local treatment plants Input to local treatment plant is based on the regional production volume. HERA at XXXI CED Kay Fox

12. Detergent Release scenario HERA Region Release is based on population density Production 200 km Formulation 200 km Use ~100% of release Kg/person/year HERA at XXXI CED Kay Fox

13. The standard EU region has 10% of the EU detergent consumption - for 5.4% of the EU population. HERA at XXXI CED Kay Fox

14. Detergent consumption per person in eighteen European countries HERA at XXXI CED Kay Fox

15. HERA at XXXI CED Kay Fox

16. The maximum regional release for detergent ingredients is found in the UK region containing London • This is 5.5% of total usage, rather than 10%, as in the TGD • Thus the HERA Detergent release scenario should have 5.5% of the total volume released to the region. HERA at XXXI CED Kay Fox

17. In EUSES, STD. EU Region Local treatment plants Input to local treatment plant is based on the regional use volume. HERA at XXXI CED Kay Fox

18. Regional detergent Scenario • HERA must give the correct local loading for sewage treatment plants in countries with highest detergent use. • Italy and Spain have 1.25 times the average EU detergent consumption, per person. • HERA ensures correct representation of the LOCAL treatment plant, which EUSES derives from the regional consumption, by raising the overall regional background to.055 X 1.25 = 0.07 times the European use volume HERA uses 7%, not 10%, for regional input EUSES HERA at XXXI CED Kay Fox

19. Product use and substance use data are expected to be similar, for most widely used detergent ingredients. • Each HERA Substance team will consider any areas of high regional usage for their substance, and will modify the HERA regional default if appropriate. Fragrance F HERA at XXXI CED Kay Fox

20. STD. EU Region Local treatment plants Release from LOCAL Sewage Treatment facility A reasonable worst case treatment plant receives 4 times the average load TGD - Local plant 4 HERA at XXXI CED Kay Fox

21. GREAT-ER GIS model which predicts chemical concentrations of household chemicals in rivers. UK data Boron used as a conservative tracer, to validate the model. 6 STP influents and effluents Monthly river water and effluent samples HERA at XXXI CED Kay Fox

22. Measured effluent boron agreed with load calculated from consumer sales volumes (1996, 28 daily composite samples from 6 treatment plants) 0.22 g/person/day • Boron in effluents: 50 treatment plants • NL 7 • Germany 6 • Italy 3 • UK 34 plants HERA at XXXI CED Kay Fox

23. UK Boron data from 804 grab samples from 34 plants. Measured to calculated boron : Mean = 1.04 90%ile < 1.5 Reasonable worst case (90%ile) is 1.5 times the regional average input, not 4 times as in the TGD default scenario. HERA at XXXI CED Kay Fox

24. Boron concentrations in Italy, Germany, and the Netherlands also agreed with the concentrations calculated for the country and year of emission, with the 90%ile of the measured to calculated boron distribution being less than 1.5. • Thus data from 50 sewage plants, in 4 countries, show that for detergent ingredients in wide general use, such as perborate, a reasonable worst case (90%ile) is 1.5 times the regional average input. • Paper on the 1.5 factor submitted to Chemosphere. ECETOC submission to TGD revision resulted in change to “up to a factor of 4” in the revised TGD. HERA at XXXI CED Kay Fox

25. Each HERA Substance team will consider any areas of high local usage for their substance, and will modify the HERA default for the reasonable worst case sewage treatment plant if appropriate. HERA at XXXI CED Kay Fox

26. Summary - HERA Defaults Detergent scenario STD. EU Region 100%, not 99%, of ingredient used goes to the local treatment facility Region - 7%, not 10% of ingredient used Local sewage treatment - 1.5 is worst case, not 4. 1.5 HERA at XXXI CED Kay Fox

27. Modified Exposure Scenario - HERA TGD - Worst case (4) (Local STW) times worst case (~2) (10% production tonnage) gives almost 8 times the average ingredient loading to a local sewage treatment plant. HERA Detergent Scenario - Data backed “worst case” (1.5) for local STW times “worst case” (~1.7) regional release based upon product use shows two times the average ingredient loading to a local sewage treatment plant. HERA will check that the substance use patterns are suitable before using the HERA defaults. HERA at XXXI CED Kay Fox

28. Thanks! • To HERA for providing the Challenges! • To the HERA Environment task force for help with the Solutions • To ERASM and the Environment Agency for England and Wales for funding the boron monitoring work • To the EA and Yorkshire Water employees who collected the samples in all weathers! • To you for listening! HERA at XXXI CED Kay Fox