Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

The American Frozen Food Institute (AFFI) appreciates the opportunity to provide feedback in response to FDAs comment request on the proposed collection of information under the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. As the voice of the U.S. frozen food industry, AFFI is the national trade association that represents the interests of all segments of the frozen food industry. AFFI members manufacture and distribute frozen foods throughout the United States and globally. AFFI represents a broad group of companies throughout the food distribution chain, including food producers, distributors, and retailers, many of whom will be preparing a food defense plan for the first time to comply with the IA rule. AFFI respectfully requests that FDA reconsider the amount of time it will take facilities to satisfy the collection of information associated with the IA rule. AFFI surveyed its members to collect data regarding the amount of time they anticipate it will take their facilities to satisfy the collection of information. Although for some tasks some members agreed with FDAs estimate or estimated time commitments below FDAs projection, in most cases our members anticipate the time burden to exceed FDAs estimates, sometimes by many orders of magnitude. Notably, our members have already begun developing their food defense plans and so the estimated time burden is based on experience performing this work. AFFI expects that the range in members estimates likely is the result of variances in facility size, the complexity of different production processes, and the number of products produced at each facility. Nevertheless, these data demonstrate that for many facilities, it will take considerably more time than FDA anticipates will be needed to comply with the rule. AFFI respectfully encourage FDA to reconsider its estimates for the information collection. Based on member feedback, the time necessary to complete the required recordkeeping for the rule will likely be far higher for most facilities than FDA anticipates. The time needed to prepare a food defense plan and record monitoring, corrective action, and verification activities, in particular, will be substantially greater than FDAs current predictions. We appreciate the opportunity to provide comment on the amount of time covered facilities must dedicate to compliance with the IA rule. Please refer to the attached document for AFFI's more detailed comments.