Mitigation Strategies to Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Availability

The American Frozen Food Institute (AFFI) appreciates the opportunity to provide feedback to the U.S. Food and Drug Administration (FDA) on the agency's third installment of the Draft Mitigation Strategies to Protect Food Against Intentional Adulteration (Draft Guidance). 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. AFFI appreciates FDA's work to prepare the final installment of the Draft Guidance, which we anticipate facilities will rely upon heavily in developing and implementing their Food Defense Plans (FDPs). As we have previously noted, the preparation of a formal, written FDP will be a significant undertaking for industry, and AFFI appreciates FDA's efforts to ensure companies have the tools needed to complete this task. Our detailed comments, which are attached, focus on the ways in which the Draft Guidance can serve as a resource to educate facilities on the ways they can develop FDPs that are compliance with the rule while making use of available flexibilities. To that end, our comments identify numerous statements in the Draft Guidance demonstrating the flexibilities available to facilities under the rule and which AFFI supports. We support the statements the guidance reinforcing the flexibility available to facilities to tailor the mitigation strategy management components to their facility. We also appreciate information in the guidance noting the differences between food safety and food defense management components. We also note several areas where we believe the Draft Guidance would benefit from further refinement to clarify (1) that facilities are not required to replicate the level of detail in their own FDPS as provided in certain examples in the guidance; (2) the distinction between inherent characteristics and mitigation strategies; and (3) FDA's approach to inspections, including the copying of FDP records.

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on the second installment of Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry (Draft Guidance). 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. AFFI appreciates FDAs release of the second installment of the Draft Guidance, which provides further information for industry on how to conduct a vulnerability assessment and in a number of ways is directly responsive to industrys requests for more information on this topic. We expect the Draft Guidance will be an important compliance tool for facilities as they prepare and implement their food defense plans (FDPs). Recognizing the role the document is likely to play in industrys compliance efforts, we would like to reiterate a request we made in our comments on the first installment with respect to FDAs plans for implementing the Draft Guidance. Specifically, we request that FDA train its investigators that the Draft Guidance (and Final Guidance) is not binding. As FDA states in the document, guidance documents are not binding on FDA or the public. Accordingly, FDA investigators should understand that the examples, model forms, and recommendations provided in the Draft Guidance are intended to serve as resources for industry, but facilities are not required to adhere to them. Relatedly, our comments below suggest recommended changes to the Draft Guidance to ensure the document reflects the full flexibility afforded under the rule. Specifically, we think the guidance would benefit from additional statements noting that facilities can take different approaches to evaluating the three fundamental elements when conducting a vulnerability assessment, as well as statements noting the inherent judgement involved when evaluating elements two and three. We also discuss the effects of the delay in the release of the Draft Guidance and the related standardized training curriculum for inspections. Additionally, we share our concerns regarding the sensitive nature of food defense plans and the implications of such for inspections. Finally, we repeat our support for FDAs statements regarding mitigation strategies and food and worker safety risks. For our detailed comments, please see the attached document.

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on the first installment of Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry (Draft Guidance). 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, each of whom may participate in the execution of a recall. FDAs implementation of the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule) marks the first time food facilities will be required to develop and implement a written Food Defense Plan (FDP). Although many facilities already have been taking measures to protect against acts of intentional adulteration, the development of a formal, written FDP will be a significant undertaking for industry. AFFI appreciates FDAs work to prepare the first installment of the Draft Guidance, which we expect will be an important compliance tool for facilities as they prepare and implement their FDPs. Recognizing the role the document is likely to play in industrys compliance efforts, we have two requests concerning FDAs process for finalizing and implementing the Draft Guidance. First, we ask that FDA not finalize this first installment until the agency has released and received comment on all installments. To that end, we support FDAs recent announcement that the agency will offer a second opportunity to provide feedback on the first installment of the Draft Guidance at the same time that it receives comment on the second installment. Should the release of the expanded guidance affect our comments on this first part, we will provide additional comments and feedback at that time. Further, FDA should not finalize any one part of the guidance until all parts of the guidance have been released and the agency has received public comments on all parts. The different chapters of the document are interconnected, and it will be important for the public to be able to review and provide comment on the complete Draft Guidance before it is finalized. Second, we request that FDA train its investigators that the Draft Guidance (and Final Guidance) is not binding. As FDA states in the document, guidance documents are not binding on FDA or the public. Accordingly, FDA investigators should understand that the examples, model forms, and recommendations provided in the Draft Guidance are intended to serve as resources for industry, but facilities are not required to adhere to them. Aside from these procedural requests, our comments below focus primarily on what we perceive to be the primary intent of the Draft Guidance: to assist facilities in developing their FDPs in the least burdensome manner possible while still achieving the objectives of the IA rule. In particular, we have identified numerous statements in the Draft Guidance that we support because they provide facilities with flexibility in how they identify and implement mitigation strategies, select monitoring procedures, and other components of compliance including creating FDP templates, forms and records. Our comments also discuss areas where we feel the Draft Guidance would benefit from additional refinement to ensure the document reflects the full flexibility afforded under the rule, as well as FDAs and industrys shared understanding that facilities should not implement mitigation strategies that could undermine food or worker safety. Please refer to the attached document for the full content of AFFI's comments.