On January 6, 2025, FDA published Draft Guidance for Industry: Establishing Sanitation Programs for Low Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event. The draft guidance is intended to assist processors of low-moisture, ready-to-eat (“LMRTE”) human foods in complying with FDA’s regulations regarding CGMPs, hazard analysis, and risk-based preventive controls at 21 CFR Part 117, as well as the infant formula requirements at 21 CFR Part 106.
Overview of the Draft Guidance
FDA’s draft guidance applies to LMRTE foods. A low-moisture food is one that exhibits a water activity of 0.85 or below, and a ready-to-eat food is “any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.” LMRTE foods can include a wide range of products, such as powdered infant formula, powdered drink mixes, medical foods in powdered and paste forms, nut butters, chocolate, dry cereal, and certain snack foods.
The draft guidance provides recommendations for establishing a routine sanitation program for LMRTE foods that can help prevent pathogen contamination events, as well as recommendations for corrective actions where prevention fails. The draft guidance is divided into three main sections. The main topics covered by each section are summarized below.
Recommendations for CGMP Measures Applicable to Sanitation Programs. FDA’s regulations at Part 117 and Part 106 contain CGMP requirements that may be applicable to a LMRTE food. In this section, FDA provides its recommendations for controlling water in dry production environments (which can enable environmental pathogen growth), routine cleaning and sanitation breaks, and equipment design and maintenance.
Recommendations for Hazard Analysis, Preventative Controls, and Associated Preventive Management Components Applicable to a Sanitation Program. FDA’s requirements relating to hazard analysis and preventive controls are primarily located in subparts C and G of 21 C.F.R. part 117, with associated requirements in subparts A, D, E, and F as well. In this section, FDA:
- Sets forth recommendations for a hazard analysis specific to each of Salmonella and Cronobacter, and for “other pertinent pathogens.” The agency also covers preventive controls (as well as monitoring and verification), and recommends that preventive controls include sanitation controls covering food contact surfaces, with monitoring and verification through visual observation.
- Explains that if contamination via an environmental pathogen is a hazard requiring a preventive control, a manufacturer must verify the controls by environmental monitoring. FDA provides recommendations for verification through environmental monitoring, and endorses a “seek and destroy” approach. FDA also recommends that manufacturers analyze data collected through environmental monitoring for trends.
- Recommends that activities to verify implementation and effectiveness include sampling and testing of finished foods, though this sampling alone is not sufficient verification of adequate control of environmental pathogens. Again, FDA recommends monitoring for trends by analyzing product testing data over time.
- Provides recommendations for establishing and implementing corrective action procedures that would apply to the detection of a pathogen or indicator microorganism in food or in an environmental sample. This subsection also provides recommendations for conducting root cause investigations and identifying affected food.
- Recommends that manufacturers characterize any pathogen isolate identified during routine verification or corrective actions and use whole genome sequencing during a root cause investigation.
- Advises that manufacturers should consider whether pathogens other than Salmonella and Cronobacter may be known or reasonably foreseeable hazards.
Recommendations for Remediation of a Pathogen Contamination Event. Finally, FDA acknowledges that the specific actions following a pathogen contamination event depend on the nature of the event and the particular regulatory framework that applies for the relevant product(s). FDA emphasizes that, absent scientific or technical information to support that dry cleaning (e.g., material flush techniques) is adequate to return a food contact substance to a “clean, dry, sanitary condition,” adequate remediation must include both cleaning and sanitizing (the latter of which is intended to destroy microorganisms). The frequency of cleaning and sanitizing could impact the extent of any market action necessary following a contamination event.
Comment Period
Interested parties should submit comments on the draft guidance by May 7, 2025.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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