Daniela D’Ippoliti

1. ARSENIC EMERGENCY IN WATER SUPPLY IN 91 MUNICIPALITIES OF THE LAZIO REGION Daniela D’Ippoliti

2. Chronic exposure to Arsenic (As) and health effects • CANCER • Oxidative DNA damage, genomic instability, aneuploidy, gene-amplification, epigenetic effects, DNA-repair inhibition leading to mutagenesis • CARDIOVASCULAR EFFECTS and ATHEROSCLEROSIS • Arrhythmia, pericarditis, ischemic heart disease, peripheral vascular disease, cerebral infarction, hypertension,subclinical arterial insufficiency, microcirculatory defects • METABOLIC EFFECTS • Diabetes mellitus -> Endocrine disruptor/inhibitor of insulin secretion • RESPIRATORY EFFECTS • Lung function decrement, COPD • REPRODUCTIVE EFFECTS • High perinatal mortality, low birth weight, spontaneous abortions, stillbirths, pre-eclampsia, congenital malformation • NEUROLOGICAL EFFECTS BACKGROUND

3. IARC Monograph Working Group

4. Scientific evidence from literature The association between high exposure (As>100 μg/L )and non-cancerous health risks is consistent, but not conlusive for low-moderate exposure (As<100 μg/L)

5. Quality standards in European Member States and in Italy 1998 Drinking Water Directive (DWD) 98/83/EC limit for As <10 μg/L “……the parametric values are based on the scientific knowledge available and the precautionary principle…….; “…..values have been selected to ensure that water intended for human consumption can be consumed safely on a life-long basis……” Before 1998As <50 μg/L Directive 80/778/EC In ITALY 2001-2003 DWD 98/83/EC was transposed into Italian law (Legislative Decree 31/01) witheffect from 2003 2003-2009 Italy obtains 3 derogations from EC to mantain As <50 μg/L 2010, February Italy asked the 4th derogation to maintain As <50 μg/Lin theLazio region, and As< 20 μg/Lin other regions 2010, October EC refused the derogation for concentrations up to 50 μg/L, while granted the derogation up to 20 μg/L

6. The EC Decision on Derogation The EC decision was based on the opinion given by the Scientific Committee on Health and Environmental Risks (SCHER) and WHO Guidelines for Drinking-water Quality 2008 SCHER opinion • Based on: • EFSA 2009 • U.S. National Research Council 2001 (COT-NRC) • 2 Meta-analysis (inconsistent evidence for low As levels) • UNCERTAINTY • Majority opinion: • The available information indicates that the requested derogation may only induce very low additional health risks in the adult population (tumor risks probably less then 1/1 000,000, much less than that predicted by the NRC-extrapolations in the range of 1.5 - 3/10,000) • Minority opinion: the risk is higher in children up to 18 years and non-breast-fed infants, in particular for levels greater than 20 µg/L. Food and air intake should also be considered.

7. As exposure in Italy Since October 2010 in Italy 128 municipalities As>10 µg/L (Lombardia, Toscana, Umbria, Lazio, Trento and Bolzano provinces) …only the Lazio region had asked derogation up to 50 µg/L Source: ARSENICO: contaminazione ed esposizione ambientale Quaderno informativo ISPESL 2010

8. STATE OF EMERGENCY in the Lazio Region D.P.C.M. Dicember 2010 Mayors ordered: it is forbidden to use water from public aqueduct for: drinking food cooking food preparation food companies

9. As exposure in the Lazio Region As mean concentrations 2004-2010 As>10 µg/L in 91 municipalities (1.060.391 inhabitants) 60 in Viterbo province 22 in Rome province 9 in Latina province The Regional Government asked the DEP to conduct a study on the association between As exposure and health effects among the resident population in the 91 municipalities

10. The evidence and the policy decisions • Regional Government questioned the EC decision because of the uncertainty in opinions and because the derogation was allowed up to 20 μg/L in the other regions • Policy makers asked the DEP to conduct a study: • to evaluate the association between health effects and low-moderate • exposure in local populations (91 municipalities) • to investigate the dose-response effect (biomonitoring measures)for • low- moderate exposure • To make decisions about the actions needed to ensure arsenic-free water

11. The Study FIRST PHASE ECOLOGICAL STUDY at municipality level Expoure As mean concentration in 2004-2010 As<10μg/L (reference group), 10μg/L<As<20μg/L, and As>20μg/L Outcomes Mortality and diseases prevalence/incidence in 1990-2010 for cancer (lung, bladder, kidney, liver, prostate), cardiovascular and respiratory diseases, diabetes and COPD Analysis Relative Risks (RR) and 95% CI through Multilevel Poisson regression model adjusted for possible confounders as socioeconomic conditions, radon exposure, and tobacco expenditure at municipality level

12. Results Significative risks for several health effects in population exposed to low-moderate As levels Viterbo province Latina province Rome province

13. Mortality for lung cancer (RR) in the 60 Municipalities of Viterbo province, 1990-2010 Males Females

14. KEY POINTS • The ecological analysis show an increased risks for several diseases associated to low-moderate As exposure (<100 μg/L) • Major limits: • No individual exposure data • No information on past exposure • Effects estimated at municipality level, while wide heterogeneity of • As concentrations within each municipality

15. Ongoing research • SECOND PHASE • Estimation of individual exposure • Cohort study based on historical residence of each subject and • geographical distribution of water supplies, associating the exposure to the • subject residence (using GIS techniques) • Lifetime exposure:timeweighted average concentration over all years over a subject’s lifetime long-term effects • Biomonitoring study • Sample measures (urine, blood samples) to estimate the dose-response • effect, and diagnostic tests to investigate pre-clinical cardiovascular • damage • 80 residents in 2 municipalities of Viterbo province, aged 18-44 years

16. CIVITA CASTELLANA Municipality (i.e.) – GIS techniques • Cohort study based on historical residence within municipality • Estimation of As exposure at spatial level (sub-area) • Sub-area exposure subject address • Areas with different levels of As exposure wthinin each municipality (heterogeneity)

17. Additional evidence may help policy makers to make decisions?

18. FUTURE CHALLENGES Policy Makers make decisions based on Economic criteria (limited resources) Political desirability Scientific evidence The fact is that to date, the Regional Government has not disseminated yet the results of the study to the local populations

19. FUTURE CHALLENGES • Evidence from the study should support policy makers to undertake actions to limit As intake in those populations with chronic exposure: • give accurate information to local populations about the severity of the risks (responsible involvement) • ensure supply of arsenic-free water both for drinking and domestic use (i.e. Mixing As contaminated water with not contaminated water, • temporary solutions) • implement structural interventions on the aquifers (although expensive) • Actually, they are the most effective measure to reduce As in drinking water