Are the strategies currently proposed for safety evaluation (risk assessment) adequate to protect sensitive populations?
The group agreed that no realistic strategy has been proposed to protect the general population, including sensitive populations. Overall, the procedures represented within the individual steps in the decision tree need to be better validated. The use of human serum for screening needs validation. Although targeted serum screening tests may be valuable, efforts need to be made to identify appropriate individuals to provide serum. In addition, the use of postmarket surveillance challenge testing (e.g., DBPCFC) could be a valuable and safe part of the evaluation process with proper study design. The use of SPTs and DBPCFCs for evaluating novel food allergens was a controversial topic. However, the group agreed that the use of postmarket surveillance skin testing (for detection of sensitization) and challenge testing (e.g., DBPCFC for establishing reactivity) presents minimal safety concerns if done properly, and therefore the benefits outweigh the risks. The value of animal testing in ev
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