Questions & Answers regarding the OECD Test Guidelines Programme (TGP)
(May 2008)
Preamble
The answers included in this document are based on Guidance Document N°1 for the Development of
OECD Guidelines for the Testing of Chemicals1, and on current practice. Procedures described can be
changed provisionally or permanently with agreement of all countries. The time needed to develop and
approve a new or revised Test Guideline is highly depending on countries’ effort to reach agreement.
The TGP produces draft Test Guidelines and other draft Test Guideline-related documents such as
validation reports, validation peer review reports, background documents, detailed review papers,
guidance documents. However, the Questions & Answers focus on the development of Test Guidelines.
What are OECD Test Guidelines?
OECD Test Guidelines are harmonized test methods included in the OECD Council Decision2 on Mutual
Acceptance of Data. This means that “data generated in the testing of chemicals in an OECD Member
country (or some non member economies3) in accordance with OECD Test Guidelines and OECD
principles of Good Laboratory Practice2 shall be accepted in other Member countries (or non member
economies) for purposes of assessment and other uses relating to the protection of man and the
environment”.
Test Guidelines, including any annex or appendix, are submitted to Council for adoption before their
publication. All other documents produced by the TGP are published in the Series on Testing and
Assessment after their declassification by the Joint Meeting.
Who oversees the TGP?
National Coordinators nominated by governments of member countries and by some non member
economies3 and the European Commission have a central position in the TGP. The Working Group of the
National Coordinators of the Test Guidelines Programme (WNT) meets once a year and oversees the work
of the TGP. The WNT reports to the Joint Meeting of the Chemicals Committee and the Working Party on
Chemicals, Pesticides and Biotechnology (Joint Meeting), which is the policy body overseeing the OECD
Chemicals Programme.
Stakeholders from industry through the Business and Industry Advisory Committee, from animal welfare
organizations through the International Council for Animal Protection in OECD Programmes, and as
appropriate, from trade unions through the Trade Union Advisory Committee, and from environmental
NGOs through the European Environmental Bureau, provide input but do not make final decisions.
1
Available
on
the
OECD
public
website
under
Chemicals
Testing
(http://www.oecd.org/env/testguidelines)
2
Available on OECD public Website under Chemical Safety (http://www.oecd.org/ehs/)
3
Adhering to the Council Acts on Mutual Acceptance of Data
1
–
Guidelines
What are the different stages of OECD Test Guideline development?
The different stages are as follows:
a) Submission of a project by a National Coordinator, the European Commission or the Secretariat, for
inclusion in the TGP work plan: a standard project submission form (SPSF) must be used (see Section 1)
b) Validation and peer review: any test method should be validated before becoming an OECD Test
Guideline (Guidance Document N°34 on the Validation and International Acceptance of New or Updated
Test Methods for Hazard Assessment2). The validation is peer reviewed via a process agreed by the WNT
(See Section 2)
d) Experts discussions and WNT agreement on the draft Test Guideline (see Section 3)
e) Adoption process from WNT approval to Council adoption (see Section 4)
1.
Project submission for inclusion in the TGP work plan
SPSFs must be submitted for projects for a new or revised Test Guideline, or for other Test Guidelinerelated documents (e.g. guidance document, detailed review paper, and background document). SPSFs are
assessed by WNT members who can (i) accept the inclusion of the project in the work plan, (ii) reject the
inclusion of the project in the work plan, or (iii) request further information.
1.1
Who can submit formal projects?
Government via their National Coordinators, the European Commission, the Secretariat and any OECD
programme (e.g. The Task Force on Biocides) can submit SPSFs. Other stakeholders can be associated
with the projects submitter.
1.2
What information is required in the SPSF?
The SPSF should inform on the work plan for the project. In order to ensure the resources necessary to the
development of a draft Test Guideline through its finalization, the SPSF should also inform on resources
that will be provided by the lead country for the validation and development of the draft Test Guideline.
Information on related regulatory needs and validation status, applicability and limitation of the methods is
requested.
1.3
When should a formal proposal be submitted to the Secretariat?
A formal proposal to develop a draft Test Guideline can be submitted at any time, but not later than 2
months before the meeting of the WNT to be assessed at that meeting.
1.4
Who decides on inclusion of projects on the work plan?
The SPSFs are assessed by the National Coordinators, the European Commission and other stakeholders
such as BIAC and ICAPO, but the decision to include a project in the work plan is made by the National
Coordinators and the European Commission only.
1.5
What main criteria should be met to include a project in the work plan?
When the WNT assesses a SPSF, it is requested to respond to the following question: “Taking into account
the project information, requested above, does this project meet the needs of the member countries for
addition to the work plan of the Test Guidelines Programme?”
A project for an OECD Test Guideline is expected to be included in the work plan if at least two countries
from different regions (North America, Europe, Asia-Pacific) consider that Test Guideline is useful.
1.6
What is an informal preliminary proposal or a preliminary SPSF?
It is possible to submit an informal preliminary proposal to gauge views of other countries on the project,
before its formal submission. The WNT is informed that a new preliminary proposal is posted on the
protected website. Any comment should be sent directly to the lead country. Preliminary proposals can be
submitted by any stakeholder, e.g. industry, with a view to finding a lead country to take over the
responsibility for the project.
2.
Validation and validation peer review
2.1
Validation status
SPSFs for Projects for Test Guidelines can be submitted at different stages of validation of the test method:
(i) ongoing pre-validation (ii) ongoing validation, or (iii) completed validation. The duration of the project
is highly dependent on the validation status, which has to be clearly described in the SPSF.
If a SPSF for a project for Test Guideline is submitted after the method has been fully validated, the
validation report and, if available, the validation peer review report, should be submitted to the Secretariat
together with the draft Test Guideline, and these documents will be made available to the WNT.
If a project of the work plan is under validation by a country, the WNT should be regularly informed of
progress, and any issue related to this validation should be reported. It is recommended that SPSF should
be submitted after the pre-validation stage, when it can be expected that validation outcome of the method
will allow the development of a Test Guideline.
2.2
Who is responsible for the validation of test methods before development of OECD Test
Guidelines?
OECD involvement in the validation of test methods is variable as shown below by examples:
Example of test method validation for endocrine disruption mechanism
For methods to detect endocrine disruption, the validation is managed by a validation management group
(VMG) on mammalian toxicity testing or a VMG on ecotoxicity testing, as appropriate. These two OECD
experts groups, which report to the WNT, decide how laboratories in countries should conduct validation
(e.g. number and identification of chemicals to be tested, reference chemicals, number of replicates,
statistical interpretation of results, and criteria for positive or negative test results, etc). An Advisory Group
on Endocrine Disrupters Testing and Assessment is requested to comment on the validation reports, and
the WNT is requested to approve the submission of the validation to the Joint Meeting for declassification
and publication in the Series on Testing and Assessment.
Given the high number of in vitro methods under development in the last years, methods are being
validated by countries, and experts from these countries report on progress with the validation at the
meetings of the VMG for non animal testing. Practically, this VMG comments and provides advice on the
validation rather than manages the validation of the test methods.
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Example of test method validation for ecotoxic effects
For simple methods for ecotoxicity testing (e.g., tests on invertabrates), one lead country (or a small group
of lead countries) is responsible for the method validation and for providing a validation report. For more
complex test methods, (e.g. test on birds or on fish embryo), specific expert groups manage the
(retrospective) validation and decide how laboratories in countries should conduct experimental validation,
if such an experimental validation is considered necessary by countries.
Example of test method validation for human health effects
In most cases, specific expert groups are established to manage retrospective validation of in vivo methods
for toxicity testing (e.g. alternative method for acute inhalation toxicity). The first draft of a retrospective
validation is usually developed by experts of the lead country or by a consultant.
For in vitro methods for toxicity testing, it is expected that most validation and peer review reports will be
developed jointly by validation/peer review bodies (ECVAM/ICCVAM/JaCVAM) and submitted jointly
by the European Commission, the United States and Japan; this should make the validation process more
efficient, and prevent request for additional experimental work or statistical analysis.
2.3
How long is the validation process?
Duration of the validation work, after a SPSF has been submitted and a project accepted, depends on the
complexity of the endpoint(s) to be tested and on the validation status of the test method at the time the
project is submitted. If the method is still at the pre-validation stage, it may take more than 2 years to
complete the validation process. For some test methods for endocrine disruption, two to three validation
phases were necessary in the past to fulfill all validation criteria, taking sometimes several years. When
appropriate data are already available, it is possible to conduct a retrospective validation, and one year may
be sufficient for the validation.
2.4
What is the process for validation peer reviews?
The OECD Secretariat has recently organized a few independent peer reviews for endocrine disrupters
screening methods, with consultants as peer review managers. International peer reviewers were proposed
by National Coordinators and confirmed by the peer review managers. Peer review packages are posted on
the public website for TGP. International independent peer reviews can also be organized by individual
countries. Circulation of the validation reports to the WNT and peer review by national experts in countries
or by OECD expert groups are considered appropriate for validation of simple test methods.
2.5
What is the follow-up to peer review reports?
Validation peer review reports are posted on the public website, accompanied by WNT agreement on the
follow-up of the peer review report. The WNT may agree on recommendations from the peer review, e.g.
to further work to complete validation, or to develop criteria or considerations, such as limitations of the
test methods, which should be included in the draft Test Guideline.
3.
WNT agreement on draft Test Guidelines
3.1
What is the process for WNT agreement on draft Test Guidelines?
The first version of a Test Guideline is usually developed by the lead country and sent to the WNT for
comments. In most cases, an expert group is established after the first commenting round to address
comments received from the WNT. These comments include compilations of comments from national
experts and national positions prepared by National Coordinators, as well as comments from other
stakeholders. The expert group meets once or several times, as appropriate. There is at least one
commenting round. Usually, 2 to 3 commenting rounds are necessary before the submission of a draft Test
Guideline to the WNT for approval. Comments are either technical comments (e.g. related to the validation
or to performance criteria) or policy comments (e.g. related to animal welfare concerns).
3.2
Who responds to comments, and revises the draft Test Guidelines?
The Secretariat, in cooperation with the lead country or an expert group, responds to comments and revises
the draft Test Guideline. Responses to technical comments are expected to be provided by the lead country
or the expert group.
3.3
What is the time needed for WNT agreement once a draft Test Guideline is available?
The time mostly depends on the number and nature of comments received from governments via their
National Coordinators, and from stakeholders, at each commenting round. It also depends on time taken by
the lead country to respond to technical comments. For the first commenting round, National Coordinators
usually have 2 months to collect comments from national experts and prepare a national position. For
subsequent commenting round, National Coordinators usually have six weeks to respond. The time taken
by lead countries to respond to technical comments varies widely with countries.
3.4
Is it possible for anyone to access the most recent draft Test Guideline?
Yes, each time a new draft is developed and available for WNT comments, it replaces the
previous draft on the public website. Draft Test Guidelines are used in some cases by industry or
governments. On the public website, warning introduces the draft Test Guidelines: “Draft Test
Guidelines are not part of Mutual Acceptance of Data. Please consult with National Authorities
before using draft Test Guidelines.”
4.
Adoption Process
The four main steps of the adoption process are:
(i) Approval at a WNT meeting
(ii) Endorsement by the Joint Meeting by written procedure
(iii) Endorsement by the Environment Policy Committee by written procedure
(iv) Adoption by the Council by written procedure
4.1
How long is the adoption process from WNT approval to Test Guidelines publication? Is it
possible to shorten the approval process?
It takes now approximately 5 month to publish Test Guidelines that have been approved by the WNT. This
time has been shortened as much as possible and it is not the bottleneck compared to the time needed for
the validation and for commenting the draft Test Guidelines. It should be noted that it is possible to use the
written procedure for WNT approval (Guidance Document N°1, Par. 22). Usually, after WNT approval,
comments are only of an editorial nature.
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