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FDA Guidance

FDA periodically publishes guidance documents for members of the food industry that help clarify specific previsions in the rule, or as to how the rule will be enforced. While these guidance documents are legally non-binding they represent the current thinking of the Food and Drug Administration (FDA) on this topic.

Recently published guidance documents with specific interest to those who must comply with the Preventive Controls for Human Food Rule are given below.

  • Control of Listeria monocytogenes in Ready-To-Eat Foods: This guidance is especially relevant to those facilities that have an environmental monitoring program, sanitation prevention controls, or process food items that have been previously associated with a Listeria monocytogenes recall. It is is intended to discuss 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.
  • Questions and Answers Regarding Food Facility Registration: This guidance is intended to answer questions about facility registration with the FDA. It is especially relevant to mixed-type facilities, restaurants, retail food establishments, and primary/secondary activities farms.
  • PCHF Compliance-Small Entity Guide: This guidance is intended to inform small entities about the details and how to comply with the Preventive Controls for Human Food Rule.
  • Human Food By-Products For Use As Animal Food: This guidance provides information for food processors that produce by-products that are used as animal food.
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food: This guidance gives information about many aspects of the Preventive Controls for Human Food Rule and is intended to help firms comply with the provisions presented in subpart C of the rule. There are only 5 chapters and 3 appendices published currently, but once the guidance is finalized there will be 14 chapters and 4 appendices. Appendix 1 is especially helpful when conducting a hazard analysis.
  • The full text of each rule, as well as all current guidance can be found on the FDA website.