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Summary Slide. Some Industry views on POP/PBT identification in Europe. Some Industry views on POP/PBT identification in Europe. Dr Dolf van Wijk – Euro Chlor Manager Environmental Sciences. Contents:. The industry perspective
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Summary Slide • Some Industry views on POP/PBT identification in Europe
Some Industry views on POP/PBT identification in Europe Dr Dolf van Wijk – Euro Chlor Manager Environmental Sciences
Contents: • The industry perspective • Learnings from Europe – PBT exercise:- Identification of T- Identification of B – proposal- Identification of P - proposal
POP identification • Different criteria in different legislations • Different interpretations of data versus criteria • Oversimplification in regulations: e.g. not ready = persistent; Hazard based, how to include risk?
Identification as Toxic In Europe usually not very controversial: • Test validity well described and agreed (Klimisch criteria) • Multiple data interpretation clear:- lowest value used- penalising data-rich substances • Criteria (LC50, NOEC) are test endpoints
Identification as Bioaccumulative • Tests less standardised, less experience, more costly • Proposal: evaluate according to OECD and define validity criteria (equilibrium-recovery, etc.) • Multiple data interpretation, e.g.:- 10 values; 2 are 5500; 8 are below?- Weight of fish, bacteria, algae, etc.? Proposal: weight of evidence • Criteria are test endpoints: BCF is measured (but often only surrogate logKow is available)
Identification as Persistent • For water: no tests exist: use (bio)degradation tests and other evidence + careful interpretation • Multiple tests: like in C&L positive test usually taken • Criteria are (mostly) not test endpoints; extrapolation to the environment extremely difficult
Persistency half-lives Half-lives for persistency are the result of many complex interactions and conditions: ‘A common finding is that biogeochemical processes in the receiving environment are as crucial to the manifestation of persistence as are the chemical properties themselves’ Pellston workshop on POPs (Setac, 1999)
P2 P2 P1 P1 P1 P1 P1 P3 P4 P4 P3 P3 1P2 Substance Yes Passes ready biodegradation test (OECD 301) No No Any other data Yes Inherent (OECD 302; OECD 301-equivalent with adapted sludge) Abiotic degradation (OECD 111; OECD Mongraph 7; OPPTS equivalents) CAS, soil, marine (OECD 303; OECD 304; OCED 306) Other evidence (non-standard; pure cultures; etc.) Rate and extent? Yes No Yes No Yes No 2P2 Accept categorisation: stop or refine: further data 1Classified as P2 due to the presence of metabolites or bound residues 2Achieved 70% degradation outside the guidance outlined in the TGD (Section 2.3.6.4)
Substance P3 P3 P3 P3 P3 P4 P4 P2 P2 P2 P2 P2 P1 P1 P1 P1 P1 P1 Screening Stage Yes Passes ready biodegradation test1 No concern No No Any other data2 Yes Abiotic degradation3 Inherent5 Other evidence CAS, soil4 or marine Accept categorisation: stop or refine: further data Default No concern Confirmatory Stage Distribution model – Level II or III6 Identify compartment(s) of interest Aquatic/ Marine 7,8 Water/ Sediment7 Soil7 Air Evidence of biodegradation: biotic and/or abiotic degradation P1 No Yes P2