In Plant Validation Update

In-Plant Validation Update


By Lynn Knipe, OSU

As you know, USDA FSIS has released a preliminary draft of the proposed In-Plant Validation Guidance material for public comment.  After FSIS has reviewed the comments and made adjustments to this draft, the guidelines will be published again, in the Federal Register.  At that time, there will be another opportunity to comment on the In-Plant Validation Guidelines. 

This article was written as an update to what was understood at the time I wrote the previous article this past April.  Dr. Dan Engeljohn, Deputy Assistant Administrator, Office of Policy and Program Development, FSIS, spoke at the Reciprocal Meat Conference this past June on the In-Plant Validation topic, and he indicated that the most vulnerable area is the slaughter process.  With the slaughter process, establishments have the most direct control of contamination, and subsequent process categories depend upon the cleanliness of the carcasses resulting from the slaughter process, meaning that the greatest attention may need to be paid to in-plant validation of the slaughter process than other process categories.

In the case of RTE (ready-to-eat) meat products it is important to know the microbial levels of incoming raw materials used to make products in order to properly validate a plan.  It is difficult to know what level of pathogen destruction is needed if you don’t know the level of contamination that you are starting with. 


A Fact Sheet was released after the In-Plant Validation Guidance Document, in which FSIS indicated that no further microbiological studies would be needed if the plant were using the guidance documentation and had records showing they are meeting the parameters.  We need to be sure that this is in the next version of the Guidance Document.  This does not mean that you would not need to do any microbial testing, but other factors can be monitored to support a process, that are much less expensive to carry out.


Parameters are factors that are important to interventions being effective in controlling hazards.  When using a scientific publication to support a process, critical parameters would be identified in the article that you would need to meet to obtain the same degree of safety as claimed in the paper.  Critical parameters for an acid rinse in a beef slaughter plan might include, for example: method of application, concentration of acid solution, pressure of equipment applying the rinse, temperature of the solution, exposure time, etc.  


Critical parameters for an RTE product might be % moisture, salt and/or sodium lactate, pH, water activity, oven humidity, internal product temperature, etc.  The challenge may be getting agreement between inspection and establishments on what are the critical parameters for each process.


In place of more expensive microbial testing, in-plant measurements could be done to show that your process meets the critical parameters.   For example, with a beef slaughter process, surface temperature indicator tags can be applied to the surface of carcasses to monitor the surface temperature, if rinse temperature is a parameter for your intervention to eliminate E. coli O157:H7.  The procedures for preparing and applying antimicrobial rinses to carcasses could be monitored, including proper mixing of (acid concentration, water temperature, etc.) the solutions.  Proper application of carcass rinse solutions to carcasses could be monitored to show proof of complete coverage.  One method that I am still working on the details for, could be to apply a food grade fluorescent substance to carcasses, that is not visible to the employee applying the carcass rinse, followed by a check with a UV light to determine if any of the fluorescent substance remains after the rinse procedure.  For those of you familiar with Glo Germ, it is not approved for food use, however, quinine water is. 


For RTE products, procedures for cleaning and preparing/applying sanitizers to equipment could be monitored, similar to what was described earlier for carcass rinses.  Proper asceptic reassembly of equipment could be monitored, as well as the use of rapid ATP-ase detection methods to determine presence of organic matter after cleaning of equipment, or the use of sanitizer detection strips, if residual sanitizer is an issue.


There are a variety of models and equations available that can add to your validation information, including the Purac Model, the ARS Pathogen Modeling Program, the AMI Lethality Equation, the University of Wisconsin’s THERM.


Smaller processors could do a lot to support their case, by plotting existing data on a graph to track and trend the data over time.  Plotting your results on a graph consolidates a lot of data on a page, and allows you and your inspectors to see trends over time that may be occurring.  You probably have more valuable historical data than you realize, if it could be plotted graphically.  A topic for another newsletter.     


Early rumors indicated that small and very small plants would have 9 months to generate the required validation data, discussed above.  We have not seen a time-line in either the guidance document or the Fact Sheet.  Dr. Dan Engeljohn stated at the Reciprocal Meat Conference in June that at the end of the timeline, FSIS would like to see data, or at least a plan in place for generating the data.


It is important to remember that guidance documents can’t be used to take regulatory action against an establishment, but they do serve as a guide to determine soundness of decisions made in HACCP plans.


It is rumored that the new guidance draft is to be issued soon.  Hopefully, this article further contributes to your understanding of this process, so that when the comment period is available for the next draft of the guidance document, you will be ready to submit helpful comments to FSIS.