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for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability
Published Date: 1/7/2025
Proposed Rule
Summary
The FDA is sharing a draft guide to help companies keep low-moisture ready-to-eat foods super clean and safe from germs. It explains how to set up cleaning routines and what to do if contamination happens. Food makers should check it out and send feedback by May 7, 2025, so the final rules can be clear and effective—helping protect customers without breaking the bank.
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
Guidance on Sanitation for LMRTE Foods
The FDA published a draft guidance that explains its current thinking on how manufacturers and processors should establish routine sanitation programs for low-moisture ready-to-eat (LMRTE) foods to help prevent contamination of food or food-contact surfaces. The guidance explains how to comply with 21 CFR part 117 and lists examples of LMRTE foods such as powdered infant formula, peanut butter, powdered drink mixes, chocolate, processed tree nuts, milk powders, spices, snack foods, granola bars, and dry cereal.
Corrective Actions After Contamination
The draft guidance explains FDA's current thinking on corrective actions to take after a pathogen contamination event, including recommendations for remediating contamination of food-contact surfaces if prevention fails. These corrective-action recommendations are intended for manufacturers and processors of LMRTE foods.
Powdered Infant Formula Coverage
The draft guidance specifically identifies powdered infant formula as an example of LMRTE food and states it is intended to help powdered infant formula manufacturers/processors comply with 21 CFR part 106.
Aims to Improve Consumer Food Safety
When finalized, the guidance's recommendations can help manufacturers and processors of LMRTE foods implement sanitation programs and hazard analysis controls that help ensure a safe and sanitary food supply for foods like peanut butter, snack foods, powdered mixes, and powdered infant formula. The draft guidance represents FDA's current thinking and is intended to help protect consumers by reducing pathogen contamination risks.
No New Paperwork Burden
The draft guidance states it contains no new collection of information. It refers to previously approved information collections: 21 CFR part 106 (OMB control number 0910-0256) and 21 CFR part 117 (OMB control number 0910-0751).
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