ENVIRONMENTAL STANDARDS AND ADVANCING RISK AND HAZARD ASSESSMENT. Dan Salvito 28 October Testing, research and outreach Testing:

Transcription

1 ENVIRONMENTAL STANDARDS AND ADVANCING RISK AND HAZARD ASSESSMENT Dan Salvito 28 October 2010 Program Elements Testing, research and outreach Testing: Materials selected via RIFM Framework (Env Stds) Materials selected to support Group Summary program Materials under study to support REACH Regulatory support: Exposure Scenarios for REACH Budget expended for testing follows the RIFM protocol for identifying manufacturers, etc. 1

2 IFRA Environmental Standards Risk based More testing required IF risk quotient >1 Insufficient data exists Typically require biodegradation and/or ecotoxicity studies Hazard based More testing required IF predictive models identify material as meeting PBT criteria Focus is on refinement of P and B For P: enhanced ready studies or die-away studies For B: OECD 305 studies 2

3 RIFM: Performs screening level review (risk or hazard) IFRA ETF provides peer review of data assessment and preliminary recommendations (for risk assessment refinement) IFRA Env Std Process RIFM revises assessment based on new data REXPAN reviews preliminary assessment and recommends additional studies, as necessary RIFM incorporates into test program or call for interested party support (consortia testing) REXPAN: Data assessment complete; provides recommendation to IFRA for risk management Distribution Pathways Atmosphere Down the Drain Disposal TREATMENT PLANT SOIL SURFACE WATERS SEDIMENTS GROUND WATER FOOD CHAIN 3

4 Risk Screening for FMs First Tier: Using only volume of use, molecular weight, and log Kow, PEC/PNEC ratios are determined Second Tier: For all those materials with PEC/PNEC >1 ECOSAR was used as an alternate QSAR PEC/PNEC ratio re-determined Exposure Characterization Calculate per capita usage and wastewater concentration Estimate removal in treatment Apply dilution factor Calculate PEC 4

5 Exposure Characterization: PEC Model assumptions: All the fragrance usage volume is discharged down the drain No volatilization occurs Both 1 and 2 treatment occurs Material removal during treatment is only the result of sorption (no biodegradation or biotransformation) Minimal dilution (a factor of 3) occurs at the mixing zone Ecological Effects Characterization: PNEC Assumption: All the fragrance is considered bioavailable QSAR Equation (Könemann, 1981): log 1/LC50 = log Kow 4.8 Assessment Factor of 10 6 used 5

6 Assessment Factors Type of Data Framewor k EU TGD Tier 1 QSAR 1,000,000 NA Tier 2 QSAR 10,000 NA Single Acute 5,000 NA Three Acutes 1,000 1,000 One Chronic Two Chronics Three Chronic Data Refinement PEC Model allows for the use of biodegradation data Input of measured WTP or in-stream data PNEC Use of alternate QSARS Collection of ecotoxicity data Method Validation Assess the ability of the model to overestimate aquatic risk No false negatives 6

7 Acetyl Cedrene: Structures and Properties CAS # Molecular Weight: Log Kow for 3 isomers: 5.6, 5.8, 5.9 Alicyclic ketone O Tier 1 and Tier 2 Risk Screening Acetyl cedrene considered not readily biodegradable ECOSAR used to calculate PNEC Assessment Factor changed to for Tier 2 PEC/PNEC >1 Measured ecotoxicological endpoints and environmental concentrations needed for further risk assessment refinement L(E)C 50 Tier 1 QSAR (ug/l) Acetyl Cedrene Tier 2 ECOSAR (ug/l) * *Neutral Organic QSAR 7

8 Degradation Aschman et al. (2001) found acetyl cedrene reactive with OH radical, O 3 and NO 3 radicals Calculated atmospheric lifetimes: OH: 1.8 hr (12 h daytime conc. 2 x 10 6 mol/cm 3 ) NO3: 11 d (12 h daytime conc. 5 x 10 8 mol/cm 3 ) O3: >7.5 d (24 h conc. 7 x mol/cm 3 ) Not readily biodegradable in standard tests Undergoes biotransformation t 1/2 of parent in activated sludge ranged from <10 minutes to 1.2 h Log K ow of metabolites ~0 ECOTOXICOLOGICAL DATA EBC 50 ERC 50 48h EC 50 96h LC 50 21d NOEC 96h NOEC PNEC (ug/l) OECD 201 OECD 201 OECD 202 OECD 203 OECD 211 OECD 201 Algae Algae Daphnia Fathead minnow Daphnia Algae Daphnia 2.80 > All values in mg/l unless otherwise noted AF = 50 8

9 US Treatment Plants (Simonich et al., 2002) Plant Type n Average PEC (3:1 Dilution Factor) Primary + Activated Sludge PEC (10:1 Dilution Factor) Oxidation Ditch Primary + Trickling Filter Primary + Rotating Biological Contactor Lagoon All values in ug/l EU Treatment Plants (Simonich et al., 2002) Plant Type n Average PEC (3:1 Dilution Factor) PEC (10:1 Dilution Factor) Primary + Activated Sludge Primary + Carousel Primary + Trickling Filter All values in ug/l 9

10 1 0 PNEC (ug/l) Activated Sludge Oxidative Ditch Trickling Filter RBC Lagoon Carousel PEC (ug/l) US 3:1 US 10:1 EU 3:1 EU 10:1 Risk Dilution Scenarios Repeat >2100 times every 4 years Process New materials are subject to a call for data via IFRA IL Materials are also checked against REACH Consortia test plans Should additional data be available risk quotients would be recalculated and rereviewed Absent additional data study bids would proceed Study protocols reviewed by ETF and Env Adjunct Group 10

11 Through an Independent Expert Panel Alison Fryer, Ph.D. Oregon Health Sciences University Portland, OR Kyoto, Japan Environmental Adjunct Group I. Glenn Sipes, PhD. (Chair) University of Arizona Tucson, AZ Donald V. Belsito, M.D. Univ. of Missouri Kansas City, MO David R. Bickers, MD Columbia University New York, NY Maria L. Z. Dagli, DVM, PhD Univ. of Sao Paolo Sao Paolo, Brazil Beate Escher, Univ of Queensland Michael Whelan, Cranfield University Prof. Magnus Bruze Malmo University Hospital Malmo, Sweden Prof. Peter Calow Roskilde University Roskilde, Denmark Prof. Dr. Helmut A. Greim Neuherberg Institut für Toxikologie Munich, Germany Jean-Hilaire Saurat, MD Universitaire de Geneve Geneva, Switzerland Yoshiki Miyachi, MD, PhD Kyoto Univ. RIFM s Environmental Research To provide methods for difficult to test substances Support of the biotransformation program Population Modeling Workshop To study fragrance materials in environments with limited understanding of chemical fate Dissipation in soils via sludge amendment Sediment bioavailability (leading towards an understanding of effects at the population level) To support the development of animal alternative methodologies and models HESI Bioaccumulation Project OECD ToolBox 11

12 Risk/Hazard Assessment: Fragrance Material Safety in Use (RHA) Technology Development: Data/Methods for Fragrance Material Characterization (TD) Issues Management: Fragrance Material Stewardship (IM) RHA REACH Exposure Scenarios Environmental Standards & Group Testing $$$ Emerging Chemicals of Concern (eg Great Lakes) Population Modeling Roskilde $$ ECETOC Scientific Committee HESI Bioaccumulation Project $ SETAC Advisory Groups & UNEP SAICM OECD Toolbox $ TD $ Budget Resource FMA - DfE/Ecolabels IM 2010 Environment al Activities Challenges Ahead Advancing Risk and Hazard Assessment SAG identified Environmental Chemicals Management as an area of concern particularly in Developing and Emerging economies: growing markets; growing interest in environmental impacts of consumer products Continued concern about initiatives related to emerging chemicals of concern Impact: Loss of materials and market limitations 12

13 Global Perspective on Wastewater Treatment UNEP: IFRA Environmental Standards Current model considers conventional risk assessment model based on Developed world scenario (e.g. USA, Western Europe) Majority of households are connected to sewage treatment plants (STPs) which treat waste water prior to discharge to freshwaters STPs remove significant concentrations of anthropogenic chemicals Acceptable environmental risk assessment often relies upon high removal rates in STPs 13

14 Scenario for many D&E countries Sewage Treatment infrastructure is often missing in D&E countries Waste water can be discharged directly into freshwaters which essentially acts as STP Freshwater ecology can be impacted by high organic matter, low DO & high free ammonia Impact Zone Requires a different approach to assessing environmental safety Direct Discharge model Three key questions to answer: Does the concentration of chemical discharged directly into a receiving water inhibit the river selfpurification process? What is the rate of removal of the chemical during the impact zone & does the chemical pose a risk to aquatic life once the river has recovered? Does the chemical present any legacy risks, i.e. persist and build up in the sediment of the impact zone that would require remediation? 14

15 Advancing Risk and Hazard Assessment: Current Conditions/Future Needs D& E EconomiesNeed to develop a Direct Discharge approach Continental/ Regional FW Aq FW Sed; Terr Risk Assessment Completed Local Manuf Plant Issue (RIFM Member responsibility) Food Chain, Metabolites Need to assure compliance with RA Hazard Assessment REACH orientated Moving towards RIFM/IFRA definition of PBT CMR also defines T Proposed scheme for chemicals management 15

16 Action steps Developing workplan with ETF and Panel Adjunct group 3 areas: Developing and Emerging Economies Initial step: With ETF and Panel Adjunct Group, review state of the science for risk assessment in D&E countries (emphasis on China, India and Brazil) Advancing Environmental Standards Review materials with complete risk/hazard assessments and determine gaps/concerns in other regions For example, HHCB is not a PBT in Europe but may be of concern in the US because of differing criteria Sustainability Support Efforts With ETF, develop proposal for Life Cycle Assessment of FMs through the manufacturing process 16