U.S – Establishments wishing to adopt the cloth sampling method (i.e., manual sampling device or continuous sampling device) for Shiga Toxin-producing Escherichia coli (STEC) testing of raw beef products will no longer require a “No Objection Letter” (NOL) from U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS).
Additionally, if employing the same parameters as their supporting literature, these establishments won’t need to collect any additional microbiological data for verifying the cloth sample method, according to FSIS.
The two components of validation, such as scientific backing and in-plant data, will still need to be supported by establishments interested in using fabric sampling, just like they would for other routine adjustments.
Page 4 of the FSIS Hazards Analysis and Critical Control Points (HACCP) Systems Validation guideline lists these components.
Establishments could use the Journal of Food Protection paper that details the cloth sampling technique that has been approved by the USDA’s Agricultural Research Service (ARS) for Element 1—Scientific Support.
A different option is to use FSIS Directive 10,010.1, Sampling Verification Activities for Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef Products, which describes the cloth sampling technique FSIS use.
The acceptance of the cloth sample procedure, says FSIS, does not constitute an endorsement of any particular cloth manufacturer, nor does FSIS “approve” any particular cloth producers.
The ability of the establishments’ sampling and testing procedures to identify STEC, which may be present at extremely low levels, must be demonstrated.
Making sure the cloth matches the one used in the supporting documentation for the sampling technique used (size, material, etc.) is one way to demonstrate this.
Any deviation from the procedure or crucial operational parameters listed in the published support can call for further backing or validation. For instance, FSIS has not approved the use of the cloth sampling method for use on frozen beef trim.
Additionally, establishments must satisfy Element 2 of validation, which entails in-plant data demonstrating their ability to meet the precise requirements of the scientific support. The standards for validating cloth sampling are the same as those for validating any other changes to the HACCP system.
There is no longer a requirement for establishments to conduct side-by-side testing comparisons of the cloth and the N60 excision (or N60+ shaver) method because FSIS has approved the cloth sample collection methodology as a reliable one.
The establishment must instead show that they have adopted and are meeting the criteria outlined in their scientific support.
The inclusion of neutralizing buffered peptone water by FSIS to the process described in the Journal of Food Protection paper in order to facilitate microbial recovery after shipping the cloth to the FSIS laboratory is one significant distinction between the two methods.
Establishments that send samples to a laboratory off-site without utilizing a transport buffer would have to defend their choice (i.e., support that a lack of neutralizing buffer does not result in reduced recovery).