FDA Food Safety Modernization Act: Focus on Implementation Strategy

The American Frozen Food Institute (AFFI) appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) docket regarding strategy for implementation of the FDA Food Safety Modernization Act (FSMA). 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 produce and distribute frozen foods throughout the United States and globally. AFFI represents a broad group of companies that will be subject to FSMA. We commend the agency for its continued outreach efforts on FSMA, including the considerable effort that has been put into consideration of industrys input throughout the rulemaking process. As FDA shifts into the next phase of FSMA implementation, we respectfully request that the agency continue this engagement and dialog. FSMA implementation is a tremendous undertaking, and it will only be successful if all of the stakeholders work in concert to develop a truly risk-based, proactive food safety system that improves the safety of all food sold in the U.S. As the agency continues its work on FSMA implementation, we encourage FDA to ensure that the following three principles are incorporated in its efforts: *Transparency: FDA has been particularly open with its stakeholders throughout the FSMA rulemakings, which we very much appreciate. This approach should continue after the final rules are published. FDA should communicate its work plans, goals, and strategies, and associated documents should be shared with industry. In particular, we are interested in working with FDA as it develops guidance for industry and training materials for inspectors. *Adaptability: Just like the regulations themselves, the agencys approach to FSMA implementation needs to recognize the wide variety of approaches that food companies take to making safe food and the broad diversity of firms in the industry. A one size fits all approach to implementation will not be effective. Rather, FDA should ensure that its strategy can be tailored to fit different needs. *Practical and Risk-Based: The core purpose of FSMA is to prevent risks to public health. FDA should always regulate with this purpose in mind, carefully selecting its inspectional targets, tailoring the scope of inspections, and focusing citations on issues that could materially affect food safety, rather than minor regulatory violations. Accordingly, the success of FSMA implementation should be based on practical, risk-based metrics that do not discourage firms from seeking out and correcting problems. In the comments that are attached, we build on these themes and provide input on (1) training and education, (2) inspections under FSMA, and (3) compliance and enforcement. Please refer to the attached document for AFFI's detailed comments.