FDA Release Draft Guidance on Sanitation Programs for Low-Moisture RTE Foods w/ Corrective Actions for Environmental Positives

FDA released a draft guidance on environmental control for manufacturers/processors of low-moisture, ready-to-eat (LMRTE) human foods, including:

• powdered infant formula (PIF), 
• peanut butter, 
• nut butters, 
• powdered drink mixes, 
• chocolate, 
• medical foods in powdered and paste forms, 
• processed tree nuts, 
• milk powders, 
• powdered spices, 
• snack foods such as chips and crackers, 
• granola bars, and
• dry cereal

The guidance is designed to help in "establishing a routine sanitation program for LMRTE foods that can help prevent pathogen contamination events and also sets forth recommendations for corrective actions, including corrective actions for remediation of contamination of food-contact surfaces (FCSs) if prevention fails.

 

Specifically, this guidance discusses:

• establishing and implementing a sanitation program and routine environmental  monitoring program; 
• conducting adequate root cause investigations (RCIs) following a pathogen contamination event; 
• applying a sanitizing7 treatment when remediating a pathogen contamination event; 
• taking steps to identify affected food; and
• the limitations of relying solely on a product testing program as verification that pathogen contamination has been eliminated

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-establishing-sanitation-programs-low-moisture-ready-eat-human-foods-and
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event
January 2025

Docket Number:
FDA-2024-D-2604

Issued by:
Human Foods Program

This guidance is intended to help manufacturers/processors of low-moisture, ready-to-eat (LMRTE) human foods comply with 21 CFR part 117 (part 117). Examples of manufactured/processed LMRTE foods that must be produced in accordance with the requirements of part 117 include powdered infant formula (PIF), peanut butter, nut butters, powdered drink mixes, chocolate, medical foods in powdered and paste forms, processed tree nuts, milk powders, powdered spices, snack foods such as chips and crackers, granola bars, and dry cereal. This guidance also is intended to help manufacturers/processors of PIF comply with 21 CFR part 106 (part 106). The recommendations in this guidance can help manufacturers/processors of LMRTE foods comply with the requirements for current good manufacturing practices (CGMPs), hazard analysis, and risk-based preventive controls to ensure a safe and sanitary food supply for these foods.

This guidance provides our current thinking on establishing a routine sanitation program for LMRTE foods that can help prevent pathogen contamination events and also sets forth recommendations for corrective actions, including corrective actions for remediation of contamination of food-contact surfaces (FCSs) if prevention fails. Specifically, this guidance discusses:

• establishing and implementing a sanitation program and routine environmental monitoring program;
• conducting adequate root cause investigations (RCIs) following a pathogen contamination event;
• applying a sanitizing treatment when remediating a pathogen contamination event;
• taking steps to identify affected food; and
• the limitations of relying solely on a product testing program as verification that pathogen contamination has been eliminated.

Although several recommendations in this guidance are specifically directed to contamination events due to environmental pathogens, the recommendations in this guidance can also be applied to contamination events with other pathogens.

In general, FDA guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.