Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability

Document 2024-31528 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on January 7, 2025. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event." The draft guidance, when finalized, will explain FDA's current thinking on establishing a routine sanitation program for low-moisture ready-to-eat human foods (LMRTE foods) that can help prevent contamination of food or a food-contact surface with a pathogen and will explain our current thinking for corrective actions, including corrective actions to remediate contamination of food-contact surfaces, if prevention fails. View the original at https://www.federalregister.gov/documents/2025/01/07/2024-31528/establishing-sanitation-programs-for-low-moisture-ready-to-eat-human-foods-and-taking-corrective.

No. Document 2024-31528 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.