“Let me get this straight, Dr. T.,” the COO said, “you want to bring microbes into our processing plant and put them into our product?!”

“That is precisely what I’m proposing,” I replied.

“And the FDA is ok with that?” he asked.

“Of course! There’s precedent for that here and here.” I pointed out.

Indeed, food process validation is required by law and using experienced scientists is critical.

FDA Requirements

AdobeStock_106446592FDA-FSMA requires validation and verification of a kill step (21 CFR 507.3). You must validate that the preventive controls identified and implemented in accordance with § 507.34 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (21 CFR 507.47). The validation must demonstrate that the food safety plan control the identified hazards. It must be performed (or overseen) by a PCQI. Currently, you are not required to validate the sanitation preventive controls, but I believe FDA should require that. (That’s a topic for a different article.)

USDA-FSIS Requirements

USDA-FSIS regulated plants have been required to validate HACCP plans and particularly CCPs long before FSMA was enacted. Under 9 CFR 417.4(a)(1) establishments are required to assemble two types of supporting documentation to demonstrate these elements are met:


  1. The scientific or technical support for the HACCP system design – that is the theoretical principles, expert advice from processing authorities, scientific or technical data, peer-reviewed journal articles, pathogen modeling programs, or other information demonstrating that particular process control measures can adequately prevent, reduce, or eliminate specific hazards; and
  2. The in-plant validation data execution – that is the in-plant observations, measurements, microbiological test results, or other information demonstrating the control measures in the HACCP system can perform as expected within a particular establishment to achieve the intended food safety objective. Under 9 CFR 417.5(a)(1) and 9 CFR 417.5(a)(2), these supporting documents must be kept for the life of the plan.

How to Perform Validation

Of course we always endeavor to perform in-plant validation using existing monitoring techniques if scientifically-valid. Sometimes we can utilize a known background microflora in raw product prior to a kill step provided that the statistical analysis supports it. The next progression is to bringing in datalogging probes such as temperature and humidity data loggers and inserting these probes into product and equipment to fully understand and document the thermodynamics. However, in many cases, the best method is to employ surrogate bacteria. For example, continuous processes or dynamic heating phases can make temperature probing very difficult if not impossible. Validating a non-thermal kill step may also necessitate surrogate bacteria.

If all else fails, such as there is not legitimate surrogate for the particular pathogen and product combination, sometimes a laboratory or pilot plant simulation can be designed to validate the process. The challenge then becomes simulating an industrial process on a laboratory scale.

Food process validation is required by law and using experienced scientists is critical.

When it comes to in-plant validation, its important to utilize an expert. I have been probing food processes and performing validations for 20 years. I was bringing surrogate bacteria into food processing plants long ago. In the past I’ve used Listeria innocua M1 (we’d never do that in this day and age). I’ve brought in lactic acid bacteria, enterics, and others. It takes careful planning and disciplined handling, followed by cleaning up and verification sampling to assure we didn’t leave anything behind.

Should you really trust your critical food process validation to a company where it will be one of many projects and handed over to a post-doc who has rarely worked in plants? Or should you trust your project to Etna Consulting Group, where you can be assured that your project is one of few and where years of experience and knowledge will be applied to your validation? The choice is yours, but the choice of whether or not to validate is not. Contact us now to schedule your food process validation now before we’re booked again.

"ETNA was able to offer expert advice and aided in the improvement of our product testing practices, environmental monitoring program, and general food safety improvements. We will continue to use ETNA consulting for as our Food Safety Consultant.”

Director of Food Safety

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