Comments RE: hazard analysis and risk-based preventive controls for human food

Draft Guidance for Industry: Chapter 11: Food Allergen Program

(Docket No. FDA-2016- D-2343)

The Center for Science in the Public Interest and the undersigned support the FDA objective of clarifying the means to create an effective food allergen control program but have concerns regarding the potential for thresholds of allowed allergen cross-contact as mentioned in this draft guidance and with the failure of the guidance to provide advice on consistent and accurate precautionary allergen labelling. The guidance also fails to prevent the intentional addition of allergens, a practice FDA has said it opposes, which is a concerning approach that has been adopted by some members of the food industry as an alternative to implementing effective but costly preventive controls.

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