Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods

July 26, 2017 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re:Control of Listeria monocytogenes in Ready-To-Eat Foods; Revised Draft Guidance for Industry; Docket No. FDA-2008-D-0096 (January 17, 2017) Dear Sir or Madam: The American Frozen Food Institute (AFFI) appreciates the opportunity to submit comments concerning the Revised Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-to-Eat Foods. 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 AFFI recognizes the significant amount of work that went into updating the 2008 Draft Guidance on Listeria control and appreciates FDA's efforts to incorporate and respond to industry feedback on the Draft Guidance. In general, AFFI is supportive of the document's risk-based approach to environmental monitoring programs. The Guidance encourages manufacturers of ready-to-eat (RTE) foods to adopt a "seek and destroy" approach to environmental monitoring programs for Listeria spp. This is an approach AFFI supports. To that end, we understand the Guidance to recognize that effective environmental monitoring programs will find positive results. These results should not be punished or viewed negatively. Rather, they are a sign of robust sampling and the ubiquitous nature of the organism in the outside environment and on many raw ingredients brought into facilities. In our comments that are attached, AFFI first discusses our industry's efforts for Listeria control and then provides additional feedback on the Draft Guidance, particularly areas where we think that improvements could be made. We are supplementing these overarching and specific comments with the following appendices: Appendix 1: Critique of Policy based on Pouillot et al., (2015), by Donald W Schaffner; /, / Appendix 2: AFFI's Recommendations on FDA's Regulatory and Compliance Approach to Listeria monocytogenes (Lm) in Frozen Foods; and, Appendix 3: AFFI's Pathway to Environmental Monitoring in Frozen Food Facilities guidance and related poster AFFI appreciates your consideration of these comments. Please do not hesitate to contact us if we can provide further information that may be helpful as the agency works to finalize the Draft Guidance. We look forward to continuing to work with FDA to ensure the food industry has guidance on best practices to control Listeria monocytogenes in and reduce the instances of listeriosis. Respectfully submitted, Dr. Donna Garren Senior Vice President of Scientific and Regulatory Affairs American Frozen Food Institute

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