The FDA announced publication of an interim final rule proposing to amend the health claim regulation associating beta-glucan soluble fiber from various whole oat and barley sources with a reduced risk of coronary heart disease (21 CFR 101.81). The interim final rule would add “barley betafiber” and, if made final after a period of time for public comment, would be the third oat/barley grain to be eligible for the claim.

“Barley betafiber” is defined as “the ethanol isolated, soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley fiber, with a beta-glucan content of at least 70% on a dry weight basis (dwb).”

Solving Listeria

The FDA has published two guidance documents for public comment relating to the control of L. monocytogenes in 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 is “Guidance for Industry, Control of L. monocytogenes in Refrigerated or Frozen RTE Foods.” This memo will deal only with the guidance proposal directed to the industry.  

 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 GMPs. Although FDA states that 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.”

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.

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 of Listeria):

pH level less than or equal to 4.4.

Water activity less than or equal to 0.92.

Formulated with one or more inhibitory substances or ingredients.

Listericidal measures can be effectively used to reach the “less than 0.04cfu/g” level, which defines a food under control for Listeria:

Thermal processing.

Irradiation.

Ultraviolet light, high pressure or pulsed electrical field.

Listericidal agents.

Raw materials: Because RTE foods may include ingredients susceptible to Listeria contamination prior to reaching the processor’s facility, the guidance recommends not only the application of listericidal measures, but also 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 targeting Listeria prevention 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. The plan should include detailed corrective actions to be taken, including more sampling, more cleaning and records review, when Listeria is detected from any environmental sample taken at a facility. The plan can be written to take into consideration “supporting growth” and “non-supporting growth” RTE foods.

The guidance recommends actions to be considered for dealing with foods that may have come into contact with a Listeria-contaminated surface or area:

Application of listericidal measures.

Hand-sorting the food based upon levels of Listeria present.

Diversion to animals.

Destruction.

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.