This is a necessary read for any FDA regulated company producing RTE product where there is exposure of the product to the environment before packaging. This document discusses control, environmental monitoring, and corrective action. While less prescriptive than the earlier version (it puts more responsibility on the processor for determining risk), it is more aggressive in terms of expected controls and monitoring.
The guidance does differentiate high risk from low risk product (low risk will not support more than one log of growth), and this impacts the monitoring regiment as well as corrective action, although both low risk and high risk product require both monitoring and corrective action.
The guidance discusses product formulating for control of Listeria where that formulation must limit the growth of Listeria to less than one log. It also discusses reduction processes, and processes that are considered Listeria reduction must reduce by 5 logs.
Environmental monitoring should cover both food contact surfaces (FCS) and non-food contact surfaces (non-FCS) and they recommend Listeria ssp. FDA suggests 5 FCS and 5 non-FCS taken several hours into production. This is more aggressive than doing pre-operational swabs. They suggest a sampling frequency of monthly for low risk products and weekly for high risk products.
There is a lengthy discussion on corrective actions should an environmental sample be found positive, but much of this, as they point out, is dependent upon the particulars of the facility and the product. This passage is important to point out:
"As discussed in section II.C, L. monocytogenes is widespread in the environment, has been isolated from food packing and processing environments, and has been shown to persist in equipment and the processing environment in harborage sites. As a result, you should expect to detect the presence of Listeria spp. or L. monocytogenes on an occasional basis in environmental samples collected from your plant. As discussed in section XIII.A, the goals of an environmental monitoring program include finding L. monocytogenes and harborage sites if present in your plant and ensuring that corrective actions have eliminated L. monocytogenes and harborage sites when found in your plant. If you consistently see negative test results in environmental samples collected from your plant, we recommend that you revise your environmental monitoring procedures to add, substitute, or both add and substitute other surfaces in your plant for sample collection and testing to ensure you are not missing a source of contamination."There is also a section on finished product testing.
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