ILTA filed comments with the Food and Drug Administration on August 14 on the regulator’s Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration. The guidance supplements FDA’s food safety regulations and addresses preventing purposeful contamination along the food supply chain and the development of formal food defense plans. ILTA previously submitted comments in July 2019 in response to FDA’s first request for industry input on its original version of the draft guidance.
In this second round of comments, ILTA again asked the FDA to maintain the non-binding dynamic of the guidance, protect food defense plans as sensitive documents, and reconsider its risk assessment scenario that holds bulk liquid storage as “significantly vulnerable” to potential contamination.
ILTA also raised new concerns on two points. First, the supplemental guidance requires the development and implementation of separate food defense plans for intentional adulteration and food safety plans for unintentional adulteration. ILTA argued that FDA should incorporate new food defense requirements into the food safety framework when possible and allow food defense plans to refer to the already-in-place food safety plans if they have been approved and meet the necessary regulations. Second, ILTA was concerned that FDA would require submission to FDA of a facility’s food defense documentation within 24 hours of a formal request. ILTA asked the FDA to extend the timeline to 72 hours.
ILTA issued a press release on the comments.