External Peer Review of the Draft Screening Assessment Report on Selected C3-C5 Alcohols

To support the quality and defensibility of regulatory decision-making under the Canadian Environmental Protection Act, 1999 (CEPA), Health Canada engaged Risk Sciences International to coordinate an independent external peer review of the Draft Screening Assessment Report (DSAR) for Selected C3-C5 Alcohols, focusing specifically on tert-butanol (CAS RN 75-65-0). This group of substances had been prioritized for risk assessment based on potential human health concerns.

The client required a robust external scientific consultation process to evaluate the health effects, exposure assessments, selection of critical effect levels, and overall risk characterization presented in the DSAR. RSI was tasked with overseeing all aspects of this process. This included identifying and managing potential conflicts of interest among candidates, selecting and coordinating three qualified external reviewers, preparing review instructions and materials, and ensuring timely completion and submission of a consolidated review report.

The reviewers were asked to provide detailed and overarching comments addressing the scientific soundness of the assessment, identification of any missing toxicological or exposure data, the adequacy of the characterization of vulnerable populations, and the appropriateness of the methodologies used. Their feedback also considered the alignment of the report’s conclusions with international practices and risk management standards for similar substances.

RSI also prepared a final summary report synthesizing the reviewers’ comments and addressed any follow-up questions from Health Canada. This comprehensive review helped ensure the screening assessment met the Department's scientific standards and reflected diverse expert perspectives prior to publication.