Task Force on POPsGeneric Guidelines and Procedures

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Aim• 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

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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

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Proposed procedure UNEP

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1. Article 10 ReviewEB (Parties)

Information GatheringTFPOP

Draft Sufficiency and Effectiveness report

TFPOP

Sufficiency and Effec-tiveness report

WGSR (Parties)

DecisionEB (Parties)

Negotiate amendmentsWGSR (Parties)

Compliance ReviewIC

Adoption revised POP protocolEB Parties

3. Proposal to amend substance

Party

Secretariat

Review proposalEB (Parties)

Draft Technical reviewTFPOP

Technical reviewWGSR (Parties)

2. Re-evaluation ofexisting obligations

EB (Parties)

Draft status reportTFPOP

Status reportWGSR (Parties)

Previews proces POP protocol

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Review process - time schedulePRELIMINARIESInstallation 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

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Review process - time scheduleREVIEW 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)

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Review process - time scheduleFOLLOW 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

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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

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Review process - review committee• Time period: January 2005 - April 2005• Review committee: 3 persons per dossier

– who volunteers– who takes the lead

• Estimated time needed: 1-2 weeks/person• Contact

– mainly by e-mail or telephone– gathering 2x

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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

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Review process - review committee• TF POP June 2005 - 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)

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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

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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 text4. DATA VALIDITY– is the quality of the data supporting the POP status

sufficiently ?

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Review process - proposed approach• Tiered or stepwise approach:

5. OTHER TOPICS– does the dossier cover the other topics sufficiently

• obligatory• optional

6. OTHER TOPICS - CONCLUSIONSdoes 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)

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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]

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Review process - requirements to dossierLEVEL 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

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Review process - requirements to dossierLEVEL 1 & 2: COMPLETENESS AND FORMAT• General structural formula

– include or not• Physical chemical data

– which– conform international guidelines (OECD)

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Review process - requirements to dossierLEVEL 3: POP CRITERIAPOP indicative values

– Potential long range transportt1/2 > 2 daysP < 1000 Pameasurements in remote areas

– Toxicitycriterium

– Persistencywater

– BioaccumulationBCF > 5000Log Kow > 5

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Review process - requirements to dossierLEVEL 3: POP CRITERIA• Potential long range transport

– only based on VP 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

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Review process - requirements to dossierLEVEL 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)

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Review process - requirements to dossierLEVEL 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

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Summary• Generic guidelines• Stepwise approach• Focus on key data• Decisions on details by review committee• Tight schedule