In-Plant Validation Clarification
By Lynn Knipe, OSU, Jodi Taylor, ODA, and Mike Link, ODA
USDA FSIS has released a preliminary draft of the proposed In-Plant Validation Guidance material for public comment. The comment period has been extended to June 19, 2010. After they have reviewed the comments and made adjustments to this draft, the guidelines will be published in the Federal Register. At that time, there will be another opportunity to comment on the In-Plant Guidelines. We would highly recommend that you send your comments to FSIS whenever you have the opportunity and you can do that by either e-mail comments to: www.fsis.usda.gov/contact_us/Email_Form/index.asp?rcpt=DraftValidationGu... , or sending written comments to: Docket Clerk, USDA, FSIS, Room 2-2127, 5601 Sunnyside Avenue, Beltsville, MD 20705
This article will discuss the highlights of the proposed In-Plant Validation guidance document, and will suggest areas of our concern, in hopes that this will help you with your comments to FSIS. This is not a new regulation but a clarification of the HACCP Final Rule of 1996, regarding a requirement that all fully-inspected establishments do in-plant validation, as part of their verification procedures.
Validation has been a part of the verification principle of HACCP, from the very beginning, and its primary purpose is to ensure that critical limits at critical control points (CCPs) are adequately controlling the hazards that were identified in the HACCP plan. There are two parts to validation: 1) the scientific or technical support (i.e., supporting documentation materials) for the HACCP system and 2) the initial in-plant demonstration that proves that your HACCP system can perform as expected. What this means is that validation must demonstrate not only that the HACCP system is theoretically sound (Part 1, supporting documentation materials), but also that the establishment can implement it, as designed, to reach the desired effect (Part 2).
The draft guidance materials indicate that at least one product from each product category would need to be In-Plant Validated. It would be wise to select the worst-case scenario of products in each process category for the in-plant validation process.
The first requirement of validation is most commonly met by the use of journal articles or FSIS guidelines (Appendix A & B) and regulations, in which the critical parameters match your product and process. Critical parameters are parameters that could affect the success of the intervention and would include cooking time, temperature and oven humidity for cooked products, but could also include fat and moisture content of your product formula, etc. However, challenge studies, which involve applying the critical parameters to product that is made and inoculated with pathogens in an off-site laboratory, are an option for scientific support, but an expensive option.
As you may remember, initial validation has always been described as a process that included generating data during the initial 90-day trial period, to provide supporting documentation for decisions made in the hazard analysis, critical limits, corrective actions, monitoring and verification frequencies, to show that your HACCP plan was operating to properly control the hazards that were identified. What has not been clearly understood (or enforced) from the beginning is what the “generating data” meant.
Where the in-plant validation enters into the picture is that you may not get the same results, using your particular product formula or processing methods as you found in published research or regulations. You are going to need evidence that you can achieve what is written in the scientific documentation that you are currently using to support your HACCP plan. As mentioned earlier, these data should be generated during the initial 90 days of implementing a new HACCP system, or whenever a new or modified intervention is used in an existing HACCP system. What is not clear in the In-Plant Validation guidance document is
All critical limits (written as “critical operational parameters” in the proposed In-Plant Validation guidance materials) would need to be validated to prove that the critical limits that you have selected are working in your operation as they did in the research paper or guidelines. What is also new in this clarification is that prerequisite programs, that are used to support decisions in the hazard analysis process and provide the necessary conditions for a HACCP plan to operate effectively, also need to be included in validation activities.
In plant validation, has two parts: (1) the validation of individual interventions and (2) the validation of the HACCP System.
Validation of Individual Interventions
This will likely involve pre- and post-intervention testing, but the validation method would be based upon the type of intervention. An example of validating a cooking process intervention might include testing the product immediately before and after cooking for Total Plate Counts and Salmonella, to determine the level of reduction of bacteria due to your cooking process. For ready-to-eat products, that are processed under Alternative 3, Listeria sampling of the contact surfaces in the processing rooms would validate the required sanitation program.
Products could also be inoculated with indicator organisms before cooking to determine the level of lethality that occurred during your process, using your product formula and processing methods. Indicator organisms are non-pathogenic organisms of similar heat resistance or growth characteristics as the pathogen that you are trying to prevent, reduce or eliminate in your process, but which will not cause an environmental problem if they contaminate your facility. For example, Listeria innocua is a non-pathogenic Listeria, however, you wouldn’t want to use it as an indicator organism, as it would show up in your environmental tests for generic Listeria if it was inadvertently released onto contact surfaces, floors, etc. in your plant.
If using an indicator organism, you should have supporting documentation that the indicator organisms chosen are appropriate to validate interventions for the pathogen that you have identified as a concern in your hazard analysis.
Validation of the HACCP System
In addition to demonstrating that each intervention (CCP, prerequisite program, etc.) within a HACCP system can be implemented according to the critical limits (critical operational parameters described in the scientific technical support), in-plant validation also includes gathering data to demonstrate that the collection of interventions and process steps together in sequence produce a safe, unadulterated product. In other words, is the entire HACCP system achieving the desired result?
At a minimum, FSIS would be like to see data on the initial levels of the pathogen of concern as well as pathogen levels or presence/absence in the final packaged product. The initial data provides information on the level of contamination that you are starting with so that you know the level of reduction that your interventions need to accomplish.
Pathogens of concern, by process category, might be:
Beef slaughter and raw, ground (beef) – E. coli O157:H7
Poultry slaughter – Salmonella
Fully cooked, not shelf stable – Cooking intervention: Salmonella
- Sanitation program (Alternative 3) environmental Listeria monocytogenes
Fully cooked, shelf stable (e.g., jerky) - Salmonella
However, the proposed guidance materials indicate that “testing for levels of both indicator organisms (Total Plate Counts or accepted indicator organisms) and presence/absence of the identified hazard (pathogen testing) is essential to ensure that not only is the establishment’s HACCP system (i.e. sum of all interventions) achieving the specific log reduction as described in that hazard analysis, but also that the interventions are successful at controlling the pathogens of interest to below detectable levels for adulterants or to acceptable levels for other raw processes.”
Comment: A question that needs to be further clarified by FSIS is regarding in-plant validation of raw ground processes in which there is no intervention step used.
For smaller processors, FSIS is recommending 13 samples to be collected and analyzed at the early point in the process and 13 samples at a point after all controls have been applied (preferably finished packaged product), for a total of 26 samples. These 26 samples should be tested for the pathogens of concern (mentioned earlier) as well as for total plate counts, to give you a better indication of the level of lethality that you are achieving with the intervention method that you are using. Other indicator organisms could be used, but we are not recommended that approach initially.
In-Plant Validation Costs
Regarding the cost of In-Plant Validation, we put some 'real life' examples together, using sample costs of some local labs. For a red meat slaughter process, doing 13 tests after hide removal and again after chilling the carcass, resulted in a cost of about $2,300, a little higher than the estimated cost using the AAMP calculator. This included sampling for generic E. coli, E. coli O157:H7 and total plate counts. If the timing was right (i.e., you were able to validate this process starting in June), it appears that you should be able to use your validation tests for your annual generic E. coli testing. Otherwise, it will have to be done separately.
However, for a ready-to-eat process category (e.g., hot dogs), our calculation for 13 samples of raw materials and 13 finished product samples (total plate counts and Salmonella) and 13 environmental samples (L. monocytogenes) came to about $1,700, which was significantly lower than the AAMP calculation, since the AAMP calculation included C. botulinum, which we don’t feel would be necessary.
Comment: It would be particularly valuable for FSIS, if you could take these estimated costs for the number of process categories that you have and compare them to your annual income to demonstrate to FSIS how this will impact you financially. It seems it would have a lot more impact if you were to make the comment to FSIS that the cost of this In-Plant Validation process would amount to a fourth, or a half, etc., of your annual income. And if it came to more than your current income from your operation, the message would be very clear that it would be difficult to continue operating under these circumstances.
Establishments using existing HACCP systems developed prior to the issuance of this draft of the In-Plant Validation guidelines that do not have the documents from their initial validation on file will need to gather data according to the timeline (that FSIS will publish in the Federal Register notice that it issues clarifying the validation requirement).
Comment: Early rumors indicated that small and very small plants would have 9 months to generate the required validation data, discussed above. We think it is important to comment to FSIS that 9 months is much too short of a timeline for smaller processors to accomplish this.
Comment: Finally, we think it would be important to send comments that you appreciate the opportunity for the industry to comment on proposed validation changes and the extension of the comment period.