New OECD Guidance Document supports use of research data in regulatory assessments of chemicals
The OECD has published a new Guidance Document aimed at improving the utility and regulatory uptake of research data in risk assessments of chemicals.
The Guidance provides practical considerations and recommendations for both risk assessors and researchers. Anna Beronius at the Institute of Environmental Medicine (IMM) has been part of the OECD Expert Group that developed the Guidance Document.
Use of research data for regulatory risk assessment of chemicals and decision making is often hampered by limitations in reliability and reporting standards, since such studies are generally not conducted and reported according to regulatory standardized test guidelines. This has been pointed out as a critical gap in several instances, for example in the EU’s Chemicals Strategy for Sustainability Towards a Toxic-free Environment, which emphasizes that research data could contribute to improved regulatory assessments of chemical risks and that tools for structured and transparent evaluation and integration of such data are needed.
The new OCED Guidance provides risk assessors with recommendations and examples of tools for evaluating and incorporating academic research data more effectively into regulatory decision-making. It also provides considerations and guidance for researchers regarding study design, data documentation, and reporting standards to support acceptance and uptake in regulatory assessments.
"This new OECD Guidance marks a significant step toward bridging the gap between academic research and regulatory chemical assessments and decision making", says Anna Beronius, Associate Professor at IMM and a member of the OECD Expert Group that has developed the Guidance Document.
"Academic research can contribute essential information to fill data gaps in regulatory assessments and support efficient and protective decision-making. By using existing research data more effectively we can also avoid unnecessary testing and enhance animal welfare. What I specifically like about this Guidance is that it addresses both sides of the coin and provides support to both researchers and risk assessors in achieving these goals."
Link to document
Webinar November 14
The OECD is organizing a webinar to present the new Guidance Document on November 14, 13:00-14.30 Central European Time. More information and link to registration is available here: Webinar on the OECD Guidance Document on the Generation, Reporting and Use of Research data for Regulatory Assessments.