Mutual acceptance of data: harmonised test methods and quality assurance of data--the process explained

Area of Science:

• Chemical safety assessment
• Regulatory science
• Environmental protection

Background:

• The Organisation for Economic Co-operation and Development (OECD) functions as a discussion forum for governments, emphasizing consensus-based decision-making.
• OECD Council Decisions are binding on all Member countries, establishing international standards for chemical safety.
• The OECD Guidelines for the Testing of Chemicals are a leading international standard for chemical safety testing.

Purpose of the Study:

• To outline the process and importance of developing OECD Test Guidelines.
• To highlight the role of the Mutual Acceptance of Data (MAD) principle in international chemical safety.
• To explain the collaborative approach involving Member countries, the OECD Secretariat, and the scientific community in guideline development.

Main Methods:

• Development of OECD Test Guidelines is initiated by the OECD Secretariat, Member countries, or the scientific community.
• Proposals are discussed by National Co-ordinators, often based on Detailed Review Papers (DRPs) assessing the state-of-the-art.
• Guidelines undergo expert review, commenting rounds among Member countries, and formal adoption by the OECD Council.

Main Results:

• The OECD Test Guidelines, integrated into binding Council Decisions, facilitate the Mutual Acceptance of Data (MAD).
• Data generated according to OECD Test Guidelines and Good Laboratory Practice (GLP) is accepted across Member countries for safety assessments.
• This system enhances the protection of human health and the environment by streamlining chemical safety evaluations.

Conclusions:

• The OECD's consensus-driven process for developing Test Guidelines ensures their international acceptance and effectiveness.
• Mutual Acceptance of Data (MAD) is a cornerstone of the OECD's chemical safety program, reducing redundant testing and promoting harmonized risk assessment.
• The collaborative development and adoption process ensures that OECD Test Guidelines remain relevant and scientifically robust, supporting global chemical safety efforts.