Task Force on POPs Generic Guidelines and Procedures

TFPOP UN ECE | M.P.M. Janssen2 Aim –give an overview of the time schedule –give suggestions for a review committee –give suggestions for review process and requirements to the dossiers as a first step to come to guidelines and procedures

TFPOP UN ECE | M.P.M. Janssen3 Overview - 1 Content: –UNEP procedure –UN ECE procedure –Review process - Time schedule –Review process - Preliminaries –Review process - review committee –Review process - proposed approach –Review process - requirements to the dossier

TFPOP UN ECE | M.P.M. Janssen4 Proposed procedure UNEP

TFPOP UN ECE | M.P.M. Janssen5

6 1. Article 10 Review EB (Parties) Information Gathering TFPOP Draft Sufficiency and Effectiveness report TFPOP Sufficiency and Effec- tiveness report WGSR (Parties) Decision EB (Parties) Negotiate amendments WGSR (Parties) Compliance Review IC Adoption revised POP protocol EB Parties 3. Proposal to amend substance Party Secretariat Review proposal EB (Parties) Draft Technical review TFPOP Technical review WGSR (Parties) 2. Re-evaluation of existing obligations EB (Parties) Draft status report TFPOP Status report WGSR (Parties) Previews proces POP protocol

TFPOP UN ECE | M.P.M. Janssen7 Review process - time schedule PRELIMINARIES Installation drafting group Guidelines & Procedures(March 2004) Proposal for Review Committee (June 2004) Draft Guidelines & Procedures(June 2004) WGSR(Sept. 2004) EB decision (Dec. 2004) –which compounds –installation of review committee –adopt procedures and guidelines

TFPOP UN ECE | M.P.M. Janssen8 Review process - time schedule REVIEW PROCESS Start review work after EB (Jan. 2005) –technical review by TF POP review committee Draft Technical review (60 days?)(April 2005) Draft Technical review to WGSR(June 2005) Technical review WGSR (Sept. 2005)

TFPOP UN ECE | M.P.M. Janssen9 Review process - time schedule FOLLOW UP Dossiers at EB (Dec. 2005) –2nd group of compounds proposed (?) –accept technical reviews (?) –give WGSR mandate for negotiations WGSR(2006) –negotiate amendments EB Parties(2006) –adoption of revised POP protocol

TFPOP UN ECE | M.P.M. Janssen10 Review process - Preliminaries TF POP March 2004 –installation of drafting group on Guidelines and Procedures TF POP June 2004 –proposal draft Guidelines and Procedures –proposal Review Committee

TFPOP UN ECE | M.P.M. Janssen11 Review process - review committee Time period: January April 2005 Review committee: 3 persons per dossier –who volunteers –who takes the lead Estimated time needed: 1-2 weeks/person Contact –mainly by or telephone –gathering 2x

TFPOP UN ECE | M.P.M. Janssen12 Review process - review committee Task –peer review –no collection of new data –possible request to EMEP/WGEffects/parties Product : draft technical reviews submitted at TF POP June 2005

TFPOP UN ECE | M.P.M. Janssen13 Review process - review committee TF POP June how to organise comments on the technical reviews? Option 1. Incorporate comments during the TFPOP meeting (e.g. last 2 days) –conclusions can be included in minutes Option 2. Incorporate comments from TFPOP immediately after TFPOP meeting –should be in time for WGSR (60 days !) –expertise of the review commission present at the TFPOP Draft technical review to WGSR (Sept. 2005)

TFPOP UN ECE | M.P.M. Janssen14 Review process - proposed approach should be time efficient should focus on key data Should the reviewer check the data in original manuscripts? –Generally: NO –Exception: certain key data in case the data are doubtful Example: exposure data for BCF/toxicity (maintenance of exposure concentration) –Possible request to EMEP/WGEffects/parties

TFPOP UN ECE | M.P.M. Janssen15 Review process - proposed approach Tiered or stepwise approach (LEVELS): 1. COMPLETENESS –is the dossier complete ? (decision EB 2004) 2. FORMAT –is the dossier in the right format ? 3. POP CRITERIA –does the report support the conclusions on the POP status sufficiently ? –conclusion should be clearly linked with data in text 4. DATA VALIDITY –is the quality of the data supporting the POP status sufficiently ?

TFPOP UN ECE | M.P.M. Janssen16 Review process - proposed approach Tiered or stepwise approach: 5. OTHER TOPICS –does the dossier cover the other topics sufficiently obligatory optional 6. OTHER TOPICS - CONCLUSIONS does the conclusions reflect the data sufficiently ? 7. OTHER TOPICS - DATA QUALITY –is the data quality sufficient ? Screening list with topics on each level (yes/no)

TFPOP UN ECE | M.P.M. Janssen17 Review process - proposed approach Example biodegradation is subject obligatory/optional? [LEVEL 5] are data available? [LEVEL 5] is biodegradation handled sufficiently? [LEVEL 5] is there biodegradation and to what extent? [LEVEL 6] is the conclusion clearly linked with the data? [LEVEL 6] is the data quality sufficient?[LEVEL 7]

TFPOP UN ECE | M.P.M. Janssen18 Review process - requirements to dossier LEVEL 1 & 2: COMPLETENESS AND FORMAT Dossiers should be in the right format –preferably similar prescribed format to enhance readability Dossiers should further: –include executive summary indicating the POP status –summarise chemical identity, physical chemical characteristics shortly –mainly focus on POP criteria –include a clear link with other (inter)national fora (e.g. legislation) –Methods used should be transparant Completeness already checked by EB

TFPOP UN ECE | M.P.M. Janssen19 Review process - requirements to dossier LEVEL 1 & 2: COMPLETENESS AND FORMAT General structural formula –include or not Physical chemical data –which –conform international guidelines (OECD)

TFPOP UN ECE | M.P.M. Janssen20 Review process - requirements to dossier LEVEL 3: POP CRITERIA POP indicative values –Potential long range transport t1/2 > 2 days P < 1000 Pa measurements in remote areas –Toxicity criterium –Persistency water –Bioaccumulation BCF > 5000 Log Kow > 5

TFPOP UN ECE | M.P.M. Janssen21 Review process - requirements to dossier LEVEL 3: POP CRITERIA Potential long range transport –only based on V P or also measurements Persistence –metabolites –general or specific environmental conditions Bioaccumulation –model estimations or data –exposure through food Toxicity –generic criteria e.g. EU L110A or others

TFPOP UN ECE | M.P.M. Janssen22 Review process - requirements to dossier LEVEL 4 & 7: DATA VALIDITY Data should be complete –difficult to check Data should be reliable –certified conditions (e.g. OECD guidelines) –published in international papers –from (inter)national databases (IUCLID,HSDB)

TFPOP UN ECE | M.P.M. Janssen23 Review process - requirements to dossier LEVEL 4 & 7: DATA VALIDITY Data should be relevant –representative for UN ECE environmental conditions Data should be traceable –data should be included in dossier (addendum) –references should be included

TFPOP UN ECE | M.P.M. Janssen24 Summary Generic guidelines Stepwise approach Focus on key data Decisions on details by review committee Tight schedule