ITALIAN GUIDELINES FOR THE APPLICATION OF RISK ASSESSMENT AT CONTAMINATED SITES
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1 ITALIAN GUIDELINES FOR THE APPLICATION OF RISK ASSESSMENT AT CONTAMINATED SITES, PhD Head of the Contaminated Sites Unit APAT DALL EMERGENZA DELLE BONIFICHE AD UNA GESTIONE CONSAPEVOLE DEL TERRITORIO SEMINARIO INTERNAZIONALE 3-4 LUGLIO 2008 Centro Congressi della Cooperazione Via Segantini, 10 - Trento 1
2 Outline Risk Assessment and Italian Regulation on Contaminated Site Italian Guidelines on HH RA: overview Development of SSTL: single and multiple exposure pathways Conclusive Remarks 2
3 RA and Italian Regulation on Contaminated Sites Main Site Investigation Measured Concentration > CSC (CSC Screening Levels set by DLgs 152/06 for soil and GW) Measured Concentration < CSC (CSC Screening Levels set by DLgs 152/06 for soil and GW) Site-Specific Risk Assessment (Human Health) SSTLs calculation () Site NOT CONTAMINATED Measured Concentration < Measured Concentration > Monitoring Plan Action Required to reduce Risk (Clean-up, Exposure Pathways Interruption) 3
4 The Italian WG on RA for contaminated sites According to its institutional task of technical support to the Italian Ministry of the Environment for the management of the remediation activities of National Priority List Sites, the National Environmental Protection Agency of Italy (APAT), in cooperation with the National Health Institute (ISS), the National Institute for Prevention and Safety at Work (ISPESL) and the Regional Environmental Protection Agencies (ARPA/APPA) developed in 2005 the national guidelines for the application of human-health risk assessment (Tier II of the ASTM RBCA standard) at contaminated sites. The guidelines, titled Criteri metodologici per l applicazione dell analisi assoluta di rischio ai siti contaminate were updated in 2006 (revision 1) by adding the procedure for the development of Site Specific Target Levels. A new revision of the guidelines has been published on March 2008 (revision 2). All the documents are available in Italian on the APAT website ( + references available in English 4
5 Members of the WG on RA for contaminated sites ISPESL, National Institute for Worker s Safety ISS, National Health Institute ARTA Abruzzo ARPA Basilicata ARPA Campania ARPA Emilia Romagna ARPA Friuli Venezia-Giulia ARPA Lazio ARPA Liguria ARPA Lombardia ARPA Marche ARPA Molise ARPA Piemonte ARPA Puglia ARPA Sardegna ARPA Sicilia ARPA Toscana APPA Trento/Provincia Autonoma ARPA Umbria ARPA Valle d Aosta ARPA Veneto Emilia-Romagna Region Lombardia Region Sardegna Region Veneto Regione Lazio Region Valle del Sacco NPL site Office 5
6 Italian Guidelines on RA Human Health Risk Assessment procedure developed according to Tier II, ASTM-RBCA The manual Criteri Metodologici per l applicazione dell analisi assoluta di rischio ai siti contamiinati was published on June 2005 (rev.0) and updated on July 2006 (rev.1) and March 2008(rev.2) Available on-line (APAT website): Technical Support for the users: criterimetodologici@apat.it 6
7 1. Introduction Index (rev.2) 2. References 3. Conceptual Model Development 4. Risk Calculation and Site-Specific Target Levels Development 5. Analysis of the Softwares and Evaluation Criteria Appendixes: A-L Transport Factors Equations M Monte Carlo Approach N Sensitivity Analysis O Chemico-Physical and Toxicological Properties P Non Aqueous Phase Liquids (NAPLs) Q Site-Specific Target Levels Development R Analytical and Numerical F&T models for the unsaturated zone S Vapor intrusion in work-places T Analytical and Numerical F&T models for groundwater 7
8 References ASTM E-1739 (USA 1995) Standard guide for Risk Based Corrective Action Applied at Petroleum Release Sites-RBCA. EPA (USA 1994) Technical Backgroud Document for Soil Screening Guidance ASTM PS-104 (USA 1998) Standard provisional guide for Risk-Based Corrective Action EPA (USA 1996) Soil Screening Guidance: Fact Sheet. UNICHIM Manuale n. 196/1 Suoli e falde contaminati, analisi di rischio sito- specifica, criteri e parametri. CONCAWE Report 3/03: european oil industry guideline for risk based assessment of contaminated sites. 8
9 Softwares RBCA TOOLKIT ver. 2.0 Groudwater Seirvice Inc. (GSI) (USA 2008) BP-RISC ver. 4.0 BP Amoco Oil (UK) ROME ver. 2.1 Agenzia Nazionale per la Protezione Ambientale (IT) GIUDITTA ver. 3.1 Provincia di Milano (IT 2006) 9
10 Development of SSTLs The procedure for the development of Site Specific Target Levels (SSTLs) or described in the above mentioned guidelines can be summarized as follows: - STEP 1: Acceptable Exposure Calculation - STEP 2: POE (Point of Exposure) Concentration Calculation - STEP 3: SSTLs () calculation (single exposure pathway and multiple exposure pathways) The SSTLs () can be developed for each of the secondary sources of contamination taken into account in the guidelines: - SURFACE SOIL - SUBSURFACE SOIL - GROUNDWATER 10
11 STEP 1: Acceptable Exposure Calculation The acceptable exposure (Eacc) can be defined as follows: Eacc / SF carcinogenic contaminants Eacc THQ x RfD non carcinogenic contaminants Where: is the acceptable value for the individual risk from carcinogenic substances SF is the Slope Factor value for the contaminant of concern THQ is the acceptable value for the individual non carcinogenic risk (Target Hazard Quotient) RfD is the Reference Dose value for the contaminant of concern In the Italian guidelines for human-health risk assessment, according the indication of the National Health Insitute (ISS) the following values are set: -acceptable value for the individual (one contaminant, one or more exposure pathways) carcinogenic risk: acceptable value for the cumulative (many contaminants, one or more exposure pathways) carcinogenic risk: CUM acceptable value for individual and cumulative risk for non carcinogenic substances (Target Hazard Quotient): THQTHQCUM 1 For the Slope Factor (SF) and Reference Dose (RfD) the guidelines require the use of the values proposed in the ISPESL-ISS database (available on APAT website). 11
12 STEP 2: POE (Point of Exposure) Concentration Calculation Once defined the acceptable exposure values (Eacc), the Point of Exposure Concentration Calculation (Cpoe, acc): Cpoe, acc Eacc / EM Where EM is the effective Exposure Rate defined as the quantity of the contaminated matrix (surface soil, sub-surface soil, groundwater) directly affecting the target. The exposure pathways taken into account in the guidelines for each source of contamination are described in the following Table. SOURCES OF CONTAMINATION EXPOSURE PATHWAY Dermal Contact SURFACE SOIL (0-1 m from ground level) SUB-SURFACE SOIL (-1m to water table level) Ingestion Outdoor/Indoor Vapour Outdoor/Indoor Dust Outdoor/Indoor Vapour GROUNDWATER Outdoor/Indoor Vapour Compliance with quality objectives for GW 12
13 SSTLs for Groundwater Resource Protection In agreement with the requirements of the EU Directives 2000/60 and 2006/118 and in agreement with the Italian regulation on Environmental Liability, the guidelines set the acceptable concentration for groundwater at the Point of Exposure equal to the concentration allowing the compliance to the quality objectives established for groundwater, according to the implementation of the above mentioned EU Directives, at Point of Compliance (POC). If the quality objectives have not yet been fixed, the drinkable use is taken into account and the Cpoe, acc is set equal to CSC (groundwater) for on-site targets. Site Source (GW) POC CSC or Quality Objectives (GW) 13
14 STEP 3: SSTLs () calculation The SSTL () can be calculated through the following equation: Cpoe, acc / FT Where FT indicates the Transport Factors used for the evaluation of the migration of the contaminants from the source to the target. The above mentioned equation is valid for all the Transport Fcator with the exception of the DAF (Diluition Attenuation Factor) for which the expression is Cpoe, acc x DAF The three above described steps can be summarised by the following equations: C poe, acc FT Eacc EM FT SF EM FT carcinogenic substances C poe, acc FT E EM acc FT THQ EM RfD FT non carcinogenic substances 14
15 Equations for SSTL development: Residential use-carcinogenic CARCINOGENIC CONTAMINANTS RESIDENTIAL-RECREATIONAL USE SOURCE EXPOSURE PATHWAY ON-SITE ( * ) AND OFF-SITE RECEPTORS SURFACE SOIL SUB-SURFACE SOIL GROUNDWATER Kg suolo Ingestion SuoloSupIngS 6 SF Ing 10 Dermal Contact SuoloSupConD 6 Outdoor Vapour Indoor Vapour Outdoor Dust Indoor Dust Outdoor Vapour Indoor Vapour EM Kg Kg suolo Kg SFIng 10 EM SuoloSupInaO Ina InaOadj ss IngSadj SuoloSupInaIn Kg suolo Ina InaIadj sesp SuoloSupInaOP Kg suolo Ina InaOadj SuoloSupInaIP Kg suolo Ina InaIadj In ConDadj SuoloProfInaO Kg suolo Ina samb InaOadj SuoloProfInaI Kg suolo O Outdoor Vapour FaldaInaI L H 2 Indoor Vapour 2 SF EM VF ADF SF EM VF ADF SF EM PEF ADF SF EM PEF ADF SF VF EM ADF SFIna VFsesp EMInaIadj ADF SFIna EMInaIadj VFwesp ADF SF EM VF ADF FaldaInaO L H O Ina InaOadj wamb 15
16 Equations for SSTL development: Residential use-non carcinogenic NON CARCINOGENIC CONTAMINANTS INDUSIAL/COMMERCIAL USE SOURCE EXPOSURE PATHWAY ON-SITE ( * ) AND OFF-SITE RECEPTORS SURFACE SOIL SUB-SURFACE SOIL GROUNDWATER Kg suolo EMIngSAd 10 Ingestion SuoloSupIngS 6 Kg suolo Dermal Contact SuoloSupConD 6 Outdoor Vapour Indoor Vapour Outdoor Dust Indoor Dust Outdoor Vapour Indoor Vapour EMConDAd 10 Ing Ing Ina SuoloSupInaO InaOLav ss SuoloSupInaI Kg suolo SuoloSupInaOP Kg suolo InaOLav Kg Kg EM VF ADF Ina EMInaILav VFsesp ADF Ina EM PEF ADF EM PEF ADF Ina SuoloSupInaIP InaILav In VF EM ADF Ina SuoloProfInaO samb InaOLav SuoloProfInaI Kg suolo Outdoor Vapour 2 Indoor Vapour Ina VFsesp EMInaLav ADF Ina FaldaInaO L H O InaOLav wamb FaldaInaI L H 2O EM VF ADF Ina EMInaILav VFwesp ADF 16
17 Equations for SSTL development: Industrial use-carcinogenic CARCINOGENIC CONTAMINANTS INDUSIAL/COMMERCIAL USE SOURCE EXPOSURE PATHWAY ON-SITE ( * ) AND OFF-SITE RECEPTORS SuoloSupIngS Kg suolo Ingestion 6 SF Ing 10 Dermal Contact 6 EM Kg SuoloSupConD Kg suolo Kg SFIng 10 EM IngSLav ConDLav SURFACE SOIL SUB-SURFACE SOIL Outdoor Vapour Indoor Vapour Outdoor Dust Indoor Dust Outdoor Vapour Indoor Vapour SF EM VF ADF SF EM VF ADF SuoloSupInaO Ina InaOLav ss SuoloSupInaIn Ina InaILav sesp SF EM PEF ADF SuoloSupInaOP Ina InaOLav SF EM PEF ADF SuoloSupInaIP Ina InaILav In SF VF EM ADF SuoloProfInaO Ina samb InaOLav SuoloProfInaI Kg suolo SFIna VFsesp EMInaILav ADF GROUNDWATER Outdoor Vapour Indoor Vapour L H 2 FaldaInaO L H 2 O Ina InaOLav wamb FaldaInaI O SF EM VF ADF SFIna EMInaILav VFwesp ADF 17
18 Equations for SSTL development: Industrial use-non carcinogenic NON CARCINOGENIC CONTAMINANTS INDUSIAL/COMMERCIAL USE SOURCE EXPOSURE PATHWAY ON-SITE ( * ) AND OFF-SITE RECEPTORS SURFACE SOIL SUB-SURFACE SOIL GROUNDWATER Kg suolo EMIngSAd 10 Ingestion SuoloSupIngS 6 Kg suolo Dermal Contact SuoloSupConD 6 Outdoor Vapour Indoor Vapour Outdoor Dust Indoor Dust Outdoor Vapour Indoor Vapour EMConDAd 10 Ing Ing Ina SuoloSupInaO InaOLav ss SuoloSupInaI Kg suolo SuoloSupInaOP Kg suolo InaOLav Kg Kg EM VF ADF Ina EMInaILav VFsesp ADF Ina EM PEF ADF EM PEF ADF Ina SuoloSupInaIP InaILav In VF EM ADF Ina SuoloProfInaO samb InaOLav SuoloProfInaI Kg suolo Outdoor Vapour 2 Indoor Vapour Ina VFsesp EMInaLav ADF Ina FaldaInaO L H O InaOLav wamb FaldaInaI L H 2O EM VF ADF Ina EMInaILav VFwesp ADF 18
19 Equations for SSTL development: Protection of GW resource FOR THE PROTECTION OF GROUNDWATER RESOURCE RECEPTOR SOURCE MIGRATION PATHWAY ON-SITE ( * ) AND OFF-SITE RECEPTORS SURFACE SOIL Leaching to GW CSC LF DAF Falda 3 SuoloSupLF 10 Kg suolo ss µ g GROUNDWATER RESOURCE SUB-SURFACE SOIL GROUNDWATER Leaching to GW Groundwater Protection CSC LF DAF Falda 3 SuoloProfLF 10 Kg suolo µ g sp CSC DAF µ 3 FaldaIngW Falda 10 L H 2O g 19
20 SSTL development for multiple exposure pathways: Surface Soil CONTAMINATION SOURCE SURFACE SOIL Soil Ingestion Dermal Contact Vapour Outdoor Dust Outdoor Vapour Indoor Dust Indoor Leaching to GW + + Lower Concentration Value (SSTL) SURFACE SOIL 20
21 SSTL development for multiple exposure pathways: Sub-Surface Soil CONTAMINATION SOURCE SUB-SURFACE SOIL Vapour Outdoor Vapour Indoor Leaching to GW Lower Concentration Value (SSTL) SUB-SURFACE SOIL 21
22 SSTL development for multiple exposure pathways: Groundwater CONTAMINATION SOURCE GROUNDWATER Vapour Outdoor Vapour Indoor Quality objectives for GW (required at POC) Lower Concentration Value (SSTL) GROUNDWATER 22
23 Conclusive Remarks The guidelines developed by in co-operation with ISPESL, ISS and the Regional Environmental Protection Agencies (ARPA/APPA) represent one of the first example in Europe of standardization of the procedure for the human-health risk assessment following the ASTM RBCA standard (Tier II). The cooperation between the national research institutes involved in the activities on contaminated sites and the regional environmental control authorities (ARPA/APPA) represents an added value since the complexity of the problems related to the contaminated sites management require for a multidisciplinary approach. Furthermore the work carried on at national level on human-health risk assessment will facilitate the process of implementation of the Soil Framework Directive, currently pending approval. 23
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