OECD Testing Methods and Guidelines
The OECD Test Guidelines Programme - International Coordination by the Bf3R
In order to protect the health of consumers, the safety of chemicals, pesticides and biocides must be tested and evaluated using legally prescribed test methods. Potential testing methods are checked for their suitability at international level by the Organization for Economic Co-operation and Development (OECD) as part of the program for the assessment of the health and environmental hazards of chemicals and, if necessary, adopted as test guidelines. The aim of OECD activities is to develop test guidelines (TG) and guidance documents that correspond to the current state of knowledge and regulatory needs, and that improve animal welfare. Data from test methods must be accepted in all OECD member states if they meet the quality criteria of good laboratory practice (GLP). This principle of “mutual acceptance of data” serves to harmonise, but above all it prevents tests, especially animal tests, from being carried out repeatedly in different regions and therefore also reduces animal tests worldwide. In addition, this also ensures that alternative testing methods adopted as test guidelines can replace aspects of the classic TGs based on animal testing or even replace them entirely, or it ensures that these are based on the current state of science and technology, with special consideration of animal welfare aspects. Due to the urgent need for alternative methods as a result of the implementation of the EU Chemicals Regulation (REACH) and the 7th Amendment of the EU Cosmetics Directive, which prohibits the use of laboratory animals to test cosmetic ingredients, the development, validation and adoption of TGs based on alternative methods have been promoted in recent years.
The OECD Working Group of the National Coordinators of the Test Guidelines Programme (WNT) controls the process of accepting TGs and guidance documents. This working group consists of representatives from all OECD member states, whereby in Germany the function of the national coordinator for the area of human health is performed by the BfR. New projects are submitted via the National Coordinators using the Standard Project Submission Form (SPSF). It contains information on leadership as well as work plans and resources. The SPSF also asks about the criteria that must be met for a project to be included in the work plan of the OECD test guidelines programme. These include, above all, the regulatory requirements, the contribution to the international harmonisation of risk and substance assessment, the status of methodology development, including validation and description of the applicability domains and limitations of the method, as well as issues of intellectual property rights, but also animal welfare aspects. The annual deadline for submitting an SPSF is November 15. At an annual meeting in April, the WNT decides whether a project should be included in the work plan and then coordinates the ensuing process. The projects addressing human health are included in section 4.
To view this graphic in higher resolution, please click here
After a project has been included in the work plan, the lead country develops a test guidelines proposal, possibly with the support of an expert panel, which can then be commented by the WNT. As a rule, several rounds of comments are required before TGs or guidance documents are adopted. Depending on the progress of method development, this process may take one to two years to complete. After the adoption by the WNT, the Chemicals and Biotechnology Committee (CBC) is still required to approve the documents before they can be published and therefore recognised worldwide.
In addition to the expertise of the BfR, which is comprised in an internal working group, the National Coordinator draws on a network of national experts who are giving advice in the process of developing and revising TGs and guidance documents. Further applications for this pool of experts are always possible.
In addition to the expertise of the BfR, which is comprised in an internal working group, the National Coordinator draws on a network of national experts who are giving advice in the process of developing and revising TGs and guidance documents. Further applications for this pool of experts are always possible.
This year, TG 444A was adopted as a new test guideline in the field of human health which allows the identification of immunotoxicity in vitro. It cannot replace animal testing, but is rather intended for use in a testing strategy later on.
The first test guidelines for the investigation of eye-damaging effects were also complemented by TG 467, containing so-called defined approaches, which combine different alternative methods in a fixed data interpretation procedure.
Initial recommendations on the use of in vitro testing for developmental neurotoxicity were published with the goal of developing a testing strategy in the medium term to replace animal testing.