Contains Nonbinding Recommendations
Draft - Not for Implementation
Please Note: This guidance is being distributed for comment purposes only.
How to Comment
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance through July 17, 2017.
Submit Written Comments
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852
Submit Comments Online
Submit electronic comments on http://www.regulations.gov to docket folder FDA-2008-D-0096.
For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1700.
This guidance is intended for those persons (“you”) who are subject to our regulation, in 21 CFR part 117 (part 117), entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and who manufacture, process, pack, or hold ready-to-eat (RTE) foods. This guidance is intended for you regardless of whether you are only subject to the current good manufacturing practice requirements for human food of part 117 (CGMP requirements), the requirements for hazard analysis and risk-based preventive controls for human food in part 117 (PCHF), or both the CGMP requirements and the PCHF requirements. See section II.A of this guidance for additional information about the CGMP and PCHF requirements. This guidance is intended to help you comply with the CGMP and PCHF requirements of part 117 with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.
This guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.
This guidance also is not intended for food establishments that are not subject to part 117, such as farms.
- Download the Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (PDF: 1,336KB)
- Chapter 1: Introduction
- Chapter 2: Background
- Chapter 3: How to Apply This Guidance to Your Operations Based on the Regulatory Framework That Applies to Your Food Establishment
- Chapter 4: Controls on Personnel
- Chapter 5: Design, Construction, and Operation of Your Plant
- Chapter 6: Design, Construction, and Maintenance of Equipment
- Chapter 7: Sanitation
- Chapter 8: Controls on Raw Materials and Other Ingredients
- Chapter 9: Process Control Based on Formulating an RTE Food to Have Intrinsic Characteristics That Prevent the Growth of L. monocytogenes
- Chapter 10: Listericidal Process Control
- Chapter 11: Storage Practices and Time/Temperature Controls
- Chapter 12: Transportation
- Chapter 13: Environmental Monitoring to Verify Control of Listeria spp. or L. monocytogenes
- Chapter 14: Sampling and Testing of RTE Foods
- Chapter 15: Analysis of Data for Trends
- Chapter 16: Training
- Chapter 17: Procedures to Collect Samples, Prepare Samples for Analysis, and Test Samples for Listeria spp. or L. monocytogenes
- Chapter 18: Records
- Chapter 19: Glossary
- Chapter 20: Table of Abbreviations
- Chapter 21: References
- Appendix 1. Potential Sources of L. monocytogenes
- Appendix 2. Examples of Scenarios That Could Lead to Contamination of RTE Foods With L. monocytogenes
- Appendix 3. Schematics Relevant to Recommended Plant Design
- Appendix 4. Recommended Schedules for Routine Cleaning and Sanitizing
- Appendix 5. Recommended Procedures for Collecting Environmental Samples
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting a form.