Expert review of project description: Experimental studies investigating the risks of select amines (Part A: Human toxicity).

Abstract

A review committee was established to examine the Phase II ExSIRA Part A project proposal. The committee consisted of 3 experts in the field. Each expert carefully reviewed background material (including Phase I reports) and the Part A project description; based on this work, each expert wrote an individual review. These individual reviews were used to create a consensus review for the committee in which this report is based upon. The consensus review states that the project description as proposed is feasible and that the project team is competent to perform these investigations. However, one major comment from the committee is the consistent lack of detail regarding the study design and specific methods to be utilized. The committee recommends that this detail be documented at some point before experiments are conducted. The committee also identified a total of 11 specific comments and recommendations throughout the 4 tasks for the project ¿ many of these comments should be addressed before the project is funded.