• Regul. Toxicol. Pharmacol. · Apr 2008

    Improving the quality of risk assessments in Canada using a principle-based approach.

    • P M Forristal, D L Wilke, and L S McCarty.
    • Imperial Oil Ltd., Calgary AB Canada.
    • Regul. Toxicol. Pharmacol. 2008 Apr 1; 50 (3): 336-44.

    AbstractIn 2000, the Government of Canada issued the "Framework for Science and Technology Advice" (FSTA). This official government policy directive mandates that decision-making to protect human health and the environment should be carried out in a timely, predictable, and efficient manner. It also leaves no doubt that quality assurance and quality control (QA/QC) are required for both technical data and the decision-making process itself. Since current publicly available Canadian risk assessment guidance does not directly address quality management for the decision-making process, an evaluative scheme for CEPA risk assessments was created. For each of the six FSTA principles (early issue identification, inclusiveness, sound science and science advice, uncertainty and risk, openness and transparency, review) specific expectations were developed for performance measurement purposes. This scheme addresses the FSTA requirement for a policy compliance checklist. It could serve as the basis for quality assurance audits during risk assessment production and quality control audits in subsequent review of the risk assessment process. Among other things, it could also improve the integration of science advice, policy objectives and general risk communication by enhancing decision-making openness and transparency.

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