Article: Regulations -- April 2008
“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 ListeriaThe 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):
Listericidal measures can be effectively used to reach the “less than 0.04cfu/g” level, which defines a food under control for Listeria:
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:
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.