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Accelerating the Pace of Chemical Risk Assessment Workshop: Advancing Progress in the Use of New Alternative Methods for Regulatory Support
Citation:
Gwinn, M., T. Bahadori, M. Rasenberg, T. Sobanski, T. Barton-Maclaren, R. Thomas, AND R. Kavlock. Accelerating the Pace of Chemical Risk Assessment Workshop: Advancing Progress in the Use of New Alternative Methods for Regulatory Support. Presented at Society of Toxicology, San Antonio, TX, March 11 - 15, 2018. https://doi.org/10.23645/epacomptox.6877157
Impact/Purpose:
To bring together international regulators to discuss progress and barriers in applying new approach methods (NAMs) to prioritization, screening, and quantitative risk assessment of differing levels of complexity.
Description:
The tides of acceptance of new alternative methods (NAMs) are changing. Numerous scientific papers have been published recently that explore the boundaries of data applicability and propose approaches that bridge new and conventional methods. The modernization of the Toxic Substances Control Act, the implementation of REACH, the next phase of the Canadian Chemicals Management Plan, and many international chemical management policies and laws have escalated the demand for sharing of data and knowledge across the regulatory landscape. This surge in scientific interest and regulatory demand provided the momentum to examine how NAMs might transform regulatory evaluation of chemicals and pragmatically evaluate barriers to acceptance. These barriers include potential limitations of existing technologies, differing regulatory needs for decision making, and lack of understanding in applying NAMs. In order to better understand what is needed for the acceptance of the use of NAMs for chemical risk assessment, recent workshops were convened comprising key international regulatory agencies to discuss progress in applying the new tools to prioritization, screening, and application to quantitative risk assessment (RAs) of differing levels of complexity. Most progress has been made in screening and prioritization, but ultimately to modernize quantitative risk assessment, there is a need to demonstrate how the data and tools can be incorporated into future RAs. Scientific and regulatory needs for the quantitative application of NAMs to RAs were identified, and example case studies were undertaken as intergovernmental collaborations to address these needs. Case study topics include use of NAMs for exposure evaluation, assessing data poor chemicals, or specific chemical classes, including per- and poly-fluorinated substances. Results of these case studies will be presented and the role of the NAM to address the chemical management or risk assessment challenge will be discussed. These efforts are an important step in increasing the confidence in use and acceptance of NAMs in regulatory chemical risk assessment.
URLs/Downloads:
DOI: Accelerating the Pace of Chemical Risk Assessment Workshop: Advancing Progress in the Use of New Alternative Methods for Regulatory Support
APCRA SOT 2018 - FINAL-030518.PDF (PDF, NA pp, 481.166 KB, about PDF)