Assessment of bioaccumulation and toxicity with non-aquatic organisms

Transcription

1 Assessment of bioaccumulation and toxicity with non-aquatic organisms Gottardo S 1, Hartmann NB 1,2, Sokull-Klüttgen B 1 1 JRC, Ispra (IT); 2 DTU, Copenhagen (DK) Serving society Stimulating innovation Supporting legislation Disclaimer: The opinions expressed in this presentation do not necessarily represent the official view of the European Commission ENTR-ENV PBT Workshop Brussels, 17 December 2014

2 Outline Background Regulatory frameworks considered Bioaccumulation (B) in non-aquatic organisms Regulatory criteria, Literature criteria, Conclusions Toxicity (T) in non-aquatic organisms Regulatory criteria, Proposed approach, Conclusions Take home messages Acknowledgements 2

3 Background Substances with PBT/vPvB properties represent a concern for the environment and human health Chemical legislation aims to protect the environment as a whole but existing regulatory criteria mainly focus on aquatic compartment Aquatic and non-aquatic organisms differ for e.g. exposure, uptake, diet, metabolism, elimination (Martin et al 2003; Kelly et al 2007) Data extrapolation from aquatic to non-aquatic organisms not recommended (Martin et al 2003; OECD 2010) High Kow/very low soluble substances: exposure via food/soil more relevant; testing with aquatic organisms has limitations (OECD 2010; Ehrlich et al 2011) 3

4 Background Administrative Arrangement between ENV and JRC-IHCP on 'Scientific and technical support to safety assessment of chemicals' Review of available criteria for non-aquatic organisms used in PBT/vPvB assessment frameworks or proposed in the scientific literature Non-aquatic organisms: all organisms that occur and live in terrestrial environments and are air-breathing including top predators and humans 4

5 Background Two JRC reports: Part I Bioaccumulation Part II Toxicity Publicly available since September 2014 Reviewed by ECHA PBT Expert Group 5

6 Regulatory frameworks International and EU frameworks considered: Framework Area Regulation/Convention POP Worldwide UN ECE POP Protocol 1996; 1998 UNEP Stockholm Convention 2001; 2009 PBT/vPvB Worldwide OSPAR Convention 1992; 2009 Canada Canadian Environmental Protection Act 1999 USA Toxic Substances Control Act 1998; 2002 EU REACH Regulation 2006; REACH Annex XIII 2011 Plant Protection Products Regulation 2009 Biocidal Products Regulation 2012;

7 Regulatory frameworks International and EU frameworks considered: Framework Area Regulation/Convention Hazard Classification and Labelling Worldwide United Nations Globally Harmonised System 2005 WHO Recommended Classification of Pesticides 2009 EU Classification, Labelling & Packaging Regulation 2008 USA US EPA Pesticides Programs 2012 Canada Pest Control Products Act 2010 New Zealand Hazardous Substances and New Organisms Act Andean Community, Argentina, Mexico, etc. 7

8 B: regulatory criteria POP/PBT/vPvB frameworks: Numerical criteria based on BAF/BCF in aquatic species (e.g. > 5000 L/Kg) or log Kow (e.g. > 5) Additional qualitative criteria (e.g. Stockholm Convention): high (eco)toxicity, evidence of bioaccumulation in other organisms, monitoring in biota REACH Annex XIII (2011): all available information in a weight of evidence approach i.e. bioaccumulation in aquatic species, other information on bioaccumulation potential (e.g. in terrestrial species), information on the ability to biomagnify (e.g. BMF/TMF) BCF = Bioconcentration Factor; BAF = Bioaccumulation Factor; Kow = octanol-water partitioning coefficient; BMF = Biomagnification Factor; TMF = Trophic Magnification Factor 8

9 B: regulatory criteria Hazard Classification and Labelling frameworks: Bioaccumulation potential and degradability along with aquatic toxicity data in the procedure for classification of a substance as 'hazardous to the environment' Numerical criteria based on BCF in aquatic species ( 500 L/Kg) and log Kow ( 4): factor 10 less than cut-off values in POP/PBT/vPvB frameworks No criteria for non-aquatic organisms 9

10 B non-aq: scientific literature Bioaccumulation in non-aquatic organisms but not or less in aquatic ones, e.g.: Observed higher biomagnification in homeotherms than poikilotherms (e.g. Fisk et al 2001; Hop et al 2002) Observed biomagnification in Arctic air-respiring organisms for substances with log Kow < 5 (e.g. Kelly & Gobas 2001; Kelly & Gobas 2007) Predicted bioaccumulation in humans for substances with log Kow < 5 and/or BCF in fish < 2000 L/Kg (e.g. Czub & McLachlan 2004a;b; Tonnelier et al 2011) Examples: β-hch; 1,2,4,5 TCB; β-endosulfan; Atrazine; Dicofol; Buprofezin; Cypronidil; Parathion; Fipronil; Bromacil; etc. 10

11 B non-aq: scientific literature Proposed criteria: SCREENING BIOACCUMULATION POTENTIAL In non-aquatic organisms In humans Kow, Koa ASSESSMENT BIOACCUMULATION From soil to low trophic levels BSAF BCFsoil BCFsed BAFsoil ASSESSMENT BIOMAGNIFICATION At upper trophic levels In humans BMF, TMF, EL0.5 EBAP, AC-BAP, mmbaf, HLT, HLB, in vitro Koa = octanol-air partitioning coefficient; BSAF = Biota-Soil Accumulation Factor, EL0.5 = Elimination half-life; EBAP = Environmental Bioaccumulation Potential; AC-BAP = Arctic Contamination Bioaccumulation Potential; HLT = Whole body total elimination half-life; HTB = Whole body biotransformation half-life 11

12 B non-aq: conclusions Consensus on screening based on log Kow > 2 & log Koa > 5/6 (e.g. Kelly & Gobas 2003; Kelly et al 2007) Hydrophobicity cut-off at log Kow 9-10 under debate Multimedia exposure, biotransformation and elimination are crucial factors in screening human bioaccumulation models Consensus on assessment based on weight of evidence: both bioconcentration and biomagnification addressed by a combination of field/laboratory metrics Non-aquatic organisms and food webs to be evaluated separately from aquatic ones Elimination half-life as comprehensive metric (Goss et al 2013; Arnot et al 2014) 12

13 T: regulatory criteria POP/PBT/vPvB frameworks: Numerical criteria based on aquatic toxicity values US/Canada: L(E)C50 1 mg/l (acute) and NOEC 0.1 mg/l (long-term) In EU: NOEC or EC10 < 0.01 mg/l (factor 10 less than US/Canada) Qualitative criteria (e.g. Stockholm Convention): 'potential for damage to human health or to the environment' 13

14 T: regulatory criteria Hazard Classification and Labelling frameworks: GHS and CLP: based on toxicity data for fish, algae and crustacea L(E)C50 (acute) and NOEC or EC10 (chronic) No criteria for non-aquatic organisms UN proposal of non-aquatic criteria by working group led by Spain but never followed-up (2006; 2008) US EPA Pesticide Programs: hazard classified for avian, wild mammals, non-target insects, aquatic organisms (acute) New Zealand: hazard classified for soil environment, terrestrial vertebrates, terrestrial invertebrates, aquatic ecotoxicity (acute) 14

15 T non-aq: proposed approach Aquatic, most toxic class EU Hazard classification NOEC/ECx cut-off value EU Hazard classification L(E)C50 cut-off value / 10 / 100 EU PBT classification NOEC/EC10 cut-off value Non-aquatic, most toxic class Hazard classifications NOEC/ECx cut-off value Hazard classifications L(E)C50 cut-off value / 10 / 100 EU PBT classification NOEC/EC10 cut-off value 15

16 T non-aq: proposed approach Based on this approach, potential ranges of non-aquatic NOEC/EC10 values for PBT assessment are derived for different organism groups (soil-dwelling invertebrates, foliar invertebrates and pollinators, microorganisms, terrestrial plants, terrestrial vertebrates (birds, mammals) It is acknowledged that this is a crude approach requiring further discussions! 16

17 T non-aq: conclusions Limited information on aquatic vs non-aquatic sensitivity Toxicity criteria based on aquatic organisms assumed to be a conservative approach (Renaud et al 2004) However, higher toxicity of several pesticides in non-aquatic organisms observed (Renaud et al 2004) Proposed approach to develop non-aquatic toxicity criteria for EU PBT/vPvB frameworks needs further development and evaluation: Acute to chronic possible? Factor 100? Cut-off values based on bulk soil vs pore water? 17

18 Take home messages 1. Current regulatory frameworks may fail at identifying substances that are bioaccumulative and/or toxic in non-aquatic compartment but not or less in aquatic one 2. Criteria for screening and assessment of B in non-aquatic compartment available in the literature, which could be further developed and implemented 3. Criteria for non-aquatic hazard classification available in regulatory frameworks and literature, which could be used to derive criteria for T assessment in non-aquatic compartment 4. Impact of adjusting existing EU regulatory frameworks to account for non-aquatic compartment needs to be further evaluated 18

19 Acknowledgments The Authors thank Sylvain Bintein from DG Environment and the members of the ECHA PBT Expert Group for providing comments to draft versions of the JRC Scientific and Policy Reports on 'Review of available criteria for non-aquatic organisms within PBT/vPvB assessment frameworks' (Part I & II) 19

20 Joint Research Centre (JRC) Contact: Thank you! Serving society Stimulating innovation Supporting legislation 20

21 References (1) Arnot JAA, Brown TN, Wania F Estimating screening-level organic chemical half-lives in humans. Environ. Sci. Technol 48(1): Czub G, McLachlan MS. 2004a. A food chain model to predict the levels of lipophilic organic contaminants in humans. Environmental Toxicology and Chemistry, 23: Czub G, McLachlan MS. 2004b. Bioaccumulation Potential of Persistent Organic Chemicals in Humans. Environ Sci Technol, 38: EC (European Commission) Regulation (EC) No 1907/2006 of the European parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 6/769/EEC and Commission Directives 91/155/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union EC (European Commission) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of the European Union EC (European Commission) Commission Regulation (EU) No 253/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XIII. Official Journal of the European Union Ehrlich G, Jöhncke U, Drost W, Schulte C. Problems faced when evaluating the bioaccumulation potential of substances under REACH. Integr Environ Assess Manag Oct; 7(4): Goss KU, Brown TN, Endo S. Elimination half-life as a metric for the bioaccumulation potential of chemicals in aquatic and terrestrial food chains. Environ Toxicol Chem Jul; 32(7): Government of Canada Canadian Environmental Protection Act. Canada Gazette Part 3. Kelly BC, Gobas FAPC An Arctic Terrestrial Food-Chain Bioaccumulation Model for Persistent Organic Pollutants. Environ Sci Technol, 37:

22 References (2) Kelly BC, Ikonomou MG, Blair JD, Morin AE, Gobas FAPC Food Web-Specific Biomagnification of Persistent Organic Pollutants. Science, 317: Martin JW, Mabury SA, Solomon KR, Muir DCG. 2003a. Dietary Accumulation of Perfluorinated Acids in juvenile rainbow trout (Oncorhynchus Mykiss). Environmental Toxicology and Chemistry, 22: Martin JW, Mabury SA, Solomon KR, Muir DCG. 2003b. Bioconcentration and tissue distribution of perfluorinated acids in rainbow trout (Oncorhynchus Mykiss). Environmental Toxicology and Chemistry, 22: OECD (Organisation for Economic Co-operation and Development) OECD Test Guideline 317. Bioaccumulation in Terrestrial Oligochaetes. OSPAR, Annex VII Cut-Off Values for the Selection Criteria of the OSPAR Dynamic Selection and Prioritisation Mechanism for Hazardous Substances. OSPAR Convention for the Protection of the Marine Environment of the North-East Atlantic. Meeting of the OSPAR Commission, Malahide (Ireland), 27 June 1 July Renaud FG, Boxall ABA, Toy R, Robertson S Evaluation of approaches for terrestrial hazard classification. In: Chemosphere. no. 57, pp Tonnelier A, Coecke S, Zaldivar J-M Screening of chemicals for human bioaccumulation potential with a physiologically based toxicokinetic model. Archives of Toxicology. UN (United Nations) Globally Harmonised System of Classification and Labelling of Chemicals (GHS). First revised edition. UN (United Nations - Committee of Experts on TDG and GHS) Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals Twelfth session, 12 (p.m)-14 July 2006, Item 2 (c) of the provisional agenda, Environmental hazards, Classification criteria for the terrestrial environment. Transmitted by the expert from Spain on behalf of the group on terrestrial hazards. UN/SCEGHS/12/INF.5. Available from: UN ECE (United Nations Economic Commission for Europe) Convention on Long-range Transboundary Air Pollution and its Protocols. ECE/EB.AIR/50. UN ECE, Geneva, Switzerland. 22

23 References (3) UN ECE (United Nations Economic Commission for Europe) Executive Body Decision 1998/2 on information to be submitted and the procedure for adding substances to Annexes I, II or III to the protocol on persistent organic pollutants. ECE.EB/AIR/60. Geneve (Switzerland). UNEP (United Nations Environment Program) Final act of the Conference of Plenipotentiaries on The Stockholm Convention on Persistent Organic Pollutants. UNEP, Geneva: 44 p. UNEP (United Nations Environment Program) Stockholm Convention on Persistent Organic Pollutants (POPs) as amended in Text and Annexes. UNEP, Geneva: 63 p. US EPA (United States Environment Protection Agency) Proposed category for persistent, bioaccumulative, and toxic chemicals. Federal Register: October 5, 1998 (Vol. 63, N. 192): US EPA (United States Environmental Protection Agency) Toxic Substances Control Act. As Amended Through P.L , December 31, WHO (World Health Organisation) The WHO Recommended Classification of Pesticides by Hazard and Guidelines to Classification Available from: 23