The U.S. Food and Drug Administration has introduced draft guidance intended to help manufacturers and processors of low-moisture, ready-to-eat (LMRTE) human foods comply with 21 CFR part 117 (part 117).

Examples of manufactured or processed LMRTE foods that must be produced in accordance with the requirements of part 117 include powdered infant formula; 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 is also intended to help manufacturers and processors of powdered infant formula comply with 21 CFR part 106 (part 106).

The recommendations in this guidance can help manufacturers and processors comply with 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 the agency’s 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 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
• 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 the 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.

The FDA is accepting comments on this draft guidance until May 7.