The FDA has published two guidance documents for public comment relating to the control ofListeria monocytogenesin ready-to-eat (RTE) refrigerated and frozen foods. The first is in the form of a Compliance Policy Guide, Guidance for FDA Staff, sec. 555.320 (“CPG”); and the second, Guidance for Industry, Control ofListeria monocytogenesin Refrigerated or Frozen Ready-To-Eat Foods. This memo will deal only with the guidance proposal directed to the industry.  

The Guidance for Industry defines a RTE food as “any refrigerated or frozen food that can be suitably consumed without additional cooking; and, without regard to whether or not the food supports the growth ofListeria monocytogenes (Listeria) .”

The guidance, which reads like a Hazard Analysis of Critical Control Points (HACCP) action plan, is described as “complementing,” but not “superseding,” the codified requirements of current good manufacturing practices (GMPs), including incorporating specific references particularized to RTE foods, i.e., “should” and “shall” recommendations. Although FDA states the principles of the guidance are “not a binding set of requirements,” if a food processor operates under its own principles, it “(is) responsible for establishing their adequacy.” The guidance does not foreclose continued compliance with overlapping regulations for fish, shellfish and dairy products.

Definitions:The guidance incorporates the definitions of terms under 21 CFR 110.3 but defines additional terms as applicable to RTE foods and Listeria control: CIP; COP; critical food-contact surface; critical non-food-contact surface or area; critical surfaces and areas; and many others.

Listeristatic Formulation or Listericidal Controls

A “finished RF-RTE food” (a defined term) includes one or more listeristatic control measures (a listeristatic control measure is defined as a control measure scientifically shown to prevent the growth ofListeria): pH of less than or equal to 4.4, water activity less than or equal to 0.92 and formulated with one or more inhibitory substances or ingredients.

Listericidal measures can be effectively used to reach the “less than 0.04cfu/g” level that defines a food under control forListeria: thermal processing; irradiation; ultraviolet light, high pressure or pulsed electrical field; and listericidal agents.

Raw materials:Because RTE foods may include ingredients susceptible toListeriacontamination prior to reaching the processor’s facility, the guidance recommends not only the application of listericidal measures, but the establishment of raw ingredient supplier controls and certifications. The guidance does recognize that certain ingredient prior processing, such as retorting and pasteurization, can minimize the need for a more vigorous incoming ingredient control protocol.

Appropriate storage, storage control, design, construction (facilities and equipment) and sanitation programs specifically considering and targetingListeriaprevention should be adopted.

Written plans and procedures should be developed and implemented for the collection and testing of environmental samples from each of the defined surfaces and areas. WhenListeriais detected from any environmental sample taken at a facility, the plan should include detailed corrective actions to be taken, including more sampling, more cleaning and records review. It also should be written to consider “supporting growth” and “non-supporting growth” RTE foods.

The guidance recommends actions to be considered with foods that may have come into contact with aListeria-contaminated surface or area: application of listericidal measures; hand-sorting the food based upon levels ofListeriapresent; diversion to animals; destruction; and recall, if necessary.

Records retention: The guidance calls for two years for documentation of control measures; suppliers’ guarantees; sampling and testing; and corrective measures.

This is a brief overview of the rather lengthy Guidance for Industry and does not include the additional insights which can be obtained by also reviewing the CPG. Any RTE food processor should thoroughly review the guidance, as it will serve as the FDA’s roadmap forListeria-specific inspections, and it is recommended that, to the extent that the guidance upgrades and tightens existing GMP obligations, RTE food processors will want to examine their current operating procedures and GMP compliance protocols against the specific criteria of the guidance.