OECD Council Decision (1981)

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OECD Council Decision (1981)

Transcript Of OECD Council Decision (1981)

OECD Council Decision (1981) Mutual Acceptance of Data (MAD)
“Data generated in the testing of chemicals in an OECD Member Country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice (GLP) shall be accepted in other Member Countries for purposes of assessment and other uses relating to the protection of man and the environment.”
Æ Avoids duplication of testing by industry Æ Avoids non-tariff trade barriers Æ Reduces the number of laboratory animals used
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The Test Guidelines Programme (TGP)
z Established 1981 (ENV DIR/EHS DIV)
z MAIN TASK: Develop and revise Test Guidelines for the testing of chemicals for human health and the environment
z Original publication in 1981: 51 TG’s z Today: 100+ new or updated Guidelines z At presently 80+ projects in the work-plan
— Special activities: EDTA (VMG mammalian, eco and non-animal
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Publication of OECD Test Guidelines

z Test Guidelines are legal instruments in OECD Member countries. There are 4 series:

100 - Physical-Chemical Properties

(blue)

200 - Effects on Biotic Systems

(green)

300 - Degradation and Accumulation

(yellow)

400 - Health Effects

(pink)

z Guidance Documents z Detailed Review Papers z Background Review Papers

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THE OECD SUBMISSION AND ADOPTION PROCESS
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THE OECD SUBMISSION AND ADO PTION PRO CESS

Secretariat

Member Countries

ICAPO BIAC NGOs Int’l Orgs.

Proposal for Test Guideline (TG)
Dev elop men t
Int’l Sci. Societies

SPSF Esse ntial Criteria Desira ble Criteria

WNT

Revised Draft TG Proposal

Small ad hoc Expert Group
Valid ation ?

Meetin g s

Independent Peer R ev iew

WNT

EDTA?

Final TG Pro po s al

C o mmen ting R ou nd (s )

Draft Proposal for TG

Adopted Test

Pu b lication

JM

EPOC

C ou n cil

Gu id elin e

Imp lemen tatio n5

Standard Project Submission Form (SPSF) - Essential criteria
z Defined regulatory need/Data requirement z Contributes to the International Harmonisation
of Hazard and Risk Assessment z Addresses a health or environmental concern z Considerable support from Member countries z Lead country or Stakeholder identified
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Standard Project Submission Form (SPSF) - Desirable criteria
z Test Guideline intended for general/broad use z Scientifically valid, reliable, relevant z Addresses endpoints not yet covered z Existing national/regional protocols as a basis z Animal welfare concerns are addressed z Contributes to saving resources z For guidance documents:
— essential or helpful — linked to (a) specific TG’s or for general guidance
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TH E O EC D SUBMISSIO N AND ADO PTIO N PROC ESS

Secretariat

Mem ber Countries

I CAP O BIAC NGOs Int’l Orgs.

Proposal for Test Guideline (TG)
Development
Int’l Sci. Societies

SPSF Essential Criteria Desirable Criteria

WNT

Revised Draft TG Proposal

Small ad hoc Expert Group
Validation?

Meetings

Independent Peer Review

WNT

EDTA?

Final TG Proposal

Commenting Round(s)

Draft Proposal for TG

Adopted Test

P ublic a tion

JM

EPOC

Council

Guideline

Im plementation8

Common Stumbling-blocks in the Development Process
z Material supporting the performance/validity of the test is not attached or of poor quality
— Statistical evaluations, scientific references, validation reports, peer review reports, etc.
— Validation criteria outlined in GD No.34 Æ
z A poorly written draft Test Guideline
z A poorly defined/or changed regulatory purpose of the TG
z Low level of commitment by the lead country
z Need for Expert Consultation or DRP
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Societies SpsfHealthOecd SubmissionProposalSpsf