Hazard Analysis and Risk-Based Preventive Controls for Human Food

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on the U.S. Food and Drug Administration ("FDA" or "Agency") Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1 ("Revised Draft Appendix 1"). From manufacturers to distributors to suppliers to packagers, AFFI is proud to represent publicly traded and family-owned companies who help produce frozen foods and beverages for today's food service and retail marketplace and serve as economic pillars within their communities throughout the U.S. The frozen food industry contributes approximately $65.1 billion to U.S. GDP and accounts for 670,00 U.S. jobs. In addition to our members' strong role in economic growth, AFFI members share a commitment to food safety. AFFI and its members are grateful to FDA for its ongoing efforts to develop and refine guidance to assist industry in complying with preventive controls for human food (PCHF) guidance. AFFI has been eagerly awaiting the publication of the Revised Draft Appendix 1 since we submitted comments on the draft Appendix 1 and first chapters of the PCHF guidance that were published in 2016. The notice and comment process is a critical component of the food industry's and FDA's mutual goal of "ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production," consistent with the Food Safety Modernization Act (FSMA). We recognize that several of our comments are reflected in the Revised Draft Appendix 1, including our request to establish the purpose of Appendix 1 more clearly, to avoid making assumptions regarding whether a food is Ready-to-Eat or Not-Ready-to-Eat, as well as several specific comments about the content of the hazard tables. We greatly appreciate FDA's willingness to listen to and respond to industry as we work together to develop practical, effective, and risk-based food safety systems; a critical component of which is providing guidance to manufacturers conducting hazard analyses. Although we are encouraged by the progress made to date, AFFI has concerns with the consistency and accuracy with which FDA identifies potential hazards in certain instances in Revised Draft Appendix 1. In order for Appendix 1 to serve its purpose as a comprehensive and useful starting point for conducting a hazard analysis, we believe the Revised Draft Appendix 1 requires additional clarity and detail. In particular, we urge FDA to (1) explain how Appendix 1 will be used by inspection personnel in facility inspections; and (2) ensure there is sufficient justification to support the inclusion of potential hazards, as detailed in the attached comments.

The American Frozen Food Institute (AFFI) appreciates the opportunity to provide comments to the U.S. Food and Drug Administration ("FDA" or "Agency") regarding its request for stakeholder feedback on its Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11 - Food Allergen Controls ("Draft Guidance"). From manufacturers to distributors to suppliers to packagers, AFFI is proud to represent publicly traded and family-owned companies who help produce frozen foods and beverages for today's food service and retail marketplace and serve as economic pillars within their communities throughout the U.S. The frozen food industry contributes approximately $65.1 billion to U.S. GDP and accounts for 670,00 U.S. jobs. In addition to our members' strong role in economic growth, AFFI members share a commitment to food safety and transparently communicating information about the ingredients in the foods they produce and sell. AFFI members take allergen controls and food safety extremely seriously and appreciate FDA's work to date to publish the Draft Guidance for allergen controls. AFFI supports the comments that Consumer Brands Association (CBA) and the Food Marketing Institute (FMI) submit to this docket. We are writing separately to reinforce CBA's and FMI's comments on two issues, which we discuss in the attached comments.

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on Chapter 15 of FDA's draft Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry (Chapter 15) and draft Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry (FSVP 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 that are subject to the FDA Food Safety Modernization Act (FSMA) regulations, including food producers, distributors, and retailers. AFFI and its members are grateful to FDA for its ongoing efforts to develop guidance and other tools to assist industry in complying with these groundbreaking regulations. Robust and thoughtful guidance will be essential for understanding and complying with the new FSMA regulations, especially for small businesses. AFFI is particularly appreciative of the obvious time and resources FDA invested in developing these supplier verification guidance documents. Both documents provide additional information and clarification that will assist industry in crafting and implementing their compliance strategies, leading to quicker compliance with the regulations and improving food safety. Due to the significant overlap in the documents, AFFI has prepared these shared comments addressing both documents. First, AFFI recognizes and expresses its support for several sections in the documents that either clarify the rules or provide additional flexibility for firms in their compliance with the supplier verification regulations. Second, AFFI offers suggestions for changes to the documents to address areas where FDA's expectations for compliance exceed what firms are able to achieve due to practical constraints of common industry practices. Finally, we also identify additional opportunities to improve the documents by addressing additional questions and concerns from industry, including in particular areas where additional flexibility would facilitate compliance. Further discussion of these and other topics are detailed in the attached document.

February 27, 2018 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Filed electronically at regulations.gov Re: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry; Chapter SixUse of Heat Treatments as a Process Control (Docket No. FDA-2016-D-2343) (Aug. 31, 2017) Dear Sir or Madam: The American Frozen Food Institute (AFFI) appreciates the opportunity to submit comments to the U.S. Food and Drug Administration ("FDA" or "the agency") regarding Chapter 6 of the agency's Draft Guidance on Hazard Analysis and RiskBased Preventive Controls for Human Food: Use of Heat Treatments as a Process Control ("Draft Guidance"). AFFI is the national trade association representing the interests of U.S. frozen food processors and their suppliers. AFFI members manufacture and distribute frozen foods throughout the United States and globally. AFFI and its members supported the passage of the FDA Food Safety Modernization Act (FSMA) and have been committed to working with FDA to implement this important food safety law. Guidance documents such as Chapter 6 of the agency's Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food play a significant role in helping educate the food industry on various methods and approaches to producing safe food and on compliance with the Preventive Controls rule. We appreciate the work that went into developing the Draft Guidance and in general are supportive of Draft Guidance. For detailed comments, please see attachment. Thanking you, Sincerely, Donna Garren

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on the Food and Drug Administration's (FDA's) draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. 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 that are subject to the FDA Food Safety Modernization Act (FSMA) regulations, including food producers, distributors, and retailers. Our members are hard at work developing their compliance strategies for the Preventive Controls for Human Food (PCHF) regulation and the other FSMA rules, which together constitute the most substantial reform of the country's food safety laws in many decades. AFFI and its members are grateful to FDA for its ongoing efforts to develop guidance and other tools to assist industry in complying with these groundbreaking regulations. Robust and thoughtful guidance will be essential for understanding and complying with the new FSMA regulations, especially for small businesses. For these reasons, AFFI wishes to thank FDA for dedicating substantial resources to developing the PCHF draft guidance. Although we expect the guidance to eventually become an indispensable tool for many businesses, we are concerned that FDA has not yet made it sufficiently clear to industry and regulators that the guidance is intended to serve as a compliance resource, not to establish new requirements. The guidance should reflect the flexibility FDA provided companies in the PCHF final rule when it comes to issues such as developing and implementing a food safety plan (FSP), however we are concerned that as written the document will become a prescriptive set of expectations that could be enforced like a regulation. We are particularly focused on the content and application of Appendix 1, which we believe is "not ready for prime time" and should be withdrawn pending substantial revisions and the addition of citations supporting the agency's conclusions. Our comments first provide general feedback on the main chapters of the comments, followed by general comments on Appendix 1 and detailed comments on Appendix 1. In particular, we discuss the following issues: The primary audience of the PCHF guidance will be small and medium-sized companies, as they will be most reliant upon guidance to develop their FSPs. To better assist these companies in developing their compliance strategies, FDA should explain why it has identified potential hazards for particular foods and provide the scientific literature or other sources that support FDA's reasoning. Without this information, many companies will be unable to determine whether a potential hazard identified in the guidance is relevant to their operations and, of so, whether the likelihood or severity of the hazard is such that the hazard is a hazard requiring a preventive control (HRPC). It is imperative that FDA make clear to all stakeholders that the guidance, and Appendix 1 in particular, is intended as a resource tool for industry, not a set of mandatory requirements. AFFI has become aware from its members that FDA investigators have begun conducting inspections using the draft Appendix 1 as a checklist for the hazards that facilities should address in their FSPs. This is problematic for several reasons. First, it is not appropriate for investigators to use the guidance as a checklist for inspections or when conducting their own hazard analyses in advance of inspections. Second, as explained below, the appendix requires substantial revision and should not be used, even as a resource, until several important issues in the guidance have been addressed. We understand that FDA plans to address the distinction between ready-to-eat (RTE) and not-ready-to-eat (NRTE) in a…